Alumni News

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The 2022 Innovation in Regulatory Science Award was
presented to Weicheng Wu, MS ’03, vice president of Global Regulatory Affairs for ASC Therapeutics, Inc., where he leads the preparation and submission of investigational new drug applications (INDs) for gene and cell therapy products and interaction with global regulatory authorities.

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Frances Richmond, Director of the USC-APEC Center for Training Excellence,  was a member of the program committee and a moderator of panel discussions for the 2021 AHC-SCH Medical Device Forum, held virtually October 14 and 21st on line, as part of joint activities with the Soonchunhyang University (SCH) APEC Center of Training Excellence, and the APEC Harmonization Center,  in Korea. This program allowed several USC graduate students in regulatory science to attend and learn about global regulatory management of digital technologies and  in vitro diagnostic devices during the current pandemic and in the future.

Click the image below or HERE to view the full agenda of the event.

Our doctoral graduates continue to use their academic capabilities! Be sure to check out the roadmap that Neal Storm and his colleagues have constructed in this paper. It describes how real-world data can be used instead of clinical bridging studies for registration in China. Read the article HERE.

Find this and lots of other articles and white papers by our alumni and faculty HERE.

Go to our Articles page and read the new piece written by former RegSci student Dr. Lori Alquier with Dr. Frances Richmond, “Streamlining processes – the WHO Collaborative Procedure for Accelerated Registration in Africa”.

Published in the September issue of TOPRA’s “Regulatory Rapporteur”.  Congrats Dr. Alquier!Regulatory Rapporeur Sept. 2021

How to Bring an IVD to Market Globally January 21st & 22nd, 2021 9am- 3pm PST | 12pm-6pm EST

Registration is now closed.  Join us for the next one!

The design process is similar between geographical regions; however, the way in which data is formatted, reviewed, and approved is very different. This course will walk through each step of the design process and then look at how this data can be used to compile global regulatory submissions to meet individual global regulatory frameworks. IVD Short Course January 2021 - title only

January 21 & 22, 2021.

Registration is now closed.  Join us for the next one!

IVD Short Course January 2021 - title only

Learn all about the USC Regulatory & Quality Sciences Program

We had a great live information session on Friday, September 18.  Our faculty spoke about our programs and their fields of expertise.  We also explored the ever-expanding job market for these skills, and looked into the burgeoning careers of recent graduates.  A question-and-answer session for the participants was held at the end of the presentation as well.

Click here to watch the video.

Information Session flyer
Click image to see the full flyer from the event

Regulatory science experts shepherd life-improving — and often lifesaving — advances from the first spark of inspiration to the marketplace, reaching those in need. This rapidly growing and global field encompasses every aspect of pharmaceutical and medical device development, quality assurance, and clinical trials oversight.

Regulatory science presents exciting careers at the intersection of science, business, and law in both the public and private sectors. Professional training in this vast and vital sphere prepares you for stimulating and rewarding jobs in which you can have a real impact on national and global health.

With our pioneering and comprehensive curriculum, the USC Department of Regulatory and Quality Sciences is internationally renowned for preparing new leaders in this dynamic industry.

We offer the big-picture foundation, hands-on skill development, global network and flexible learning options that position you for a versatile and fulfilling career as you continue to advance within the field.

Faculty News

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For more than three decades, the USC Science, Technology and Research (STAR) Program, based at the USC School of Pharmacy and supported by a USC Good Neighbors grant, has brought together USC scientists with students at Francisco Bravo Medical Magnet High School on the Health Sciences Campus.

Terry David Church, DRSc will serve as the program’s new director and Amanda Burkhardt, PhD will serve as the new co-director, opening pathways for high school students to pursue careers in life sciences, biomedical engineering and biotechnology.

Dr. Terry Church
Dr. Terry Church, new director of the USC STAR program.

We would like to acknowledge Daryl Davies, PhD for his leadership of the program over the past several years.  He has done this while serving as associate dean for undergraduate education, expanding the School of Pharmacy’s growing undergraduate programs, and while leading the research team at his own laboratory which is working to discover and develop novel therapeutics for the treatment of neurodegenerative diseases and alcoholism. Further, he has recently taken on a new leadership role at the newly established USC Institute for Addiction Science (USC IAS), the nation’s first university-wide, comprehensive, transdisciplinary addiction institute. He will continue to be a STAR mentor, training high school students in his laboratory as he has done for over 25 years.

Our doctoral graduates continue to use their academic capabilities! Be sure to check out the roadmap that Neal Storm and his colleagues have constructed in this paper. It describes how real-world data can be used instead of clinical bridging studies for registration in China. Read the article HERE.

Find this and lots of other articles and white papers by our alumni and faculty HERE.

Join our Deparatment Chair Eunjoo Pacifici and Assistant Professor Terry Church will be presenting a webinar entitled “Eastern Medicines, Western Regulation”, on Feb. 11 at 5pm PST.  Click HERE for more information, and to register for this free event!

Eastern Medicines, Western Regulation

RegSci Department faculty member Dr. Roger Clemens is among 3 authors who just published a new article titled “Coronavirus and Nutrition: What is the Evidence for Dietary Supplements Usage for COVID-19 Control and Management“.   Read this important and timely article by clicking HERE.

Assistant Professor Nancy Pire-Smerkanich was interviewed as part of an article in the Los Angeles Times titled “Why isn’t more COVID-19 vaccine available immediately?”

A worker in Scotland with a dose of the Pfizer COVID-19 vaccine

Get to know RegSci!

Take a look at our fun new scrapbook contributed to by faculty and staff of the RegSci Department!

A new article titled “Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)” by Seo, Y., & Pacifici, E. is set to be published in the November issue of Vaccine.

Go HERE to read the article.  Go HERE to see a full page of articles written by our RegSci faculty or about our Department.

The USC Dornsife East Asian Studies Center has launched a new series this year on Regulatory Science: East Asian Perspectives series which represents an exciting collaboration with colleagues at the Health Sciences Campus covering a wide range of topics on health and wellness that are of vital interest to us today.

The first webinar in the series will focus on “Drugs in COVID Times” and examine the role of East Asia in global drug development.  USC professors Eunjoo Pacifici and Terry Church will weave history and current events, and discuss the future outlook of the region.

Tuesday, October 20, 2020 | 1:00PM – 3:00PM (PDT)

Please register to attend and the Zoom link will be sent to you.

We are thrilled to announce that Dr. Terry Church has been awarded the USC Provost Interdisplinary Teaching Grant for a course on drugs and media.  What an exciting time for research and teaching! 

Members of the faculty and staff for the graduate and undergraduate programs of the Department of Regulatory and Quality Sciences have made videos congratulating all our graduates.  Find the videos at the top of our photo galleries page, HERE.

We have a new page on our site for Zoom tips and best practices.  It is specific to USC users who have USC Net ID logins and/or BlackBoard access to classes.  USC has imposed security measures on Zoom meetings to curb “Zoombombing” by unwanted participants looking for mischief.  The page will be updated as new tips or restrictions come along.

The Department of Regulatory and Quality Sciences officially welcomes Dr. Eunjoo Pacifici as the new Department Chair.  Thank you Dr. Richmond for all your years of service to the University, the School and the Department. Dr. Eunjoo Pacifici

Hangovers happen as your body tries to protect itself from alcohol’s toxic effectsDr. Daryl Davies, Dr. Terry Church along with USC PhD Candidate Joshua Silva published an article on alcohol and hangovers in The Conversation magazine.

D.K. Kim International Center for Regulatory Science Highlights

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Our own Dr. Gerald Loeb and Dr. Frances Richmond collaborated on an article for Frontiers in Robotics and AI titled “Turning Neural Prosthetics Into Viable Products”.  Go to THIS PAGE and scroll down to the White Papers section to read the article.

Town and Gown of USC is a non-profit philanthropic organization that supports USC through student scholarships, building and campus enhancements, and cultural programs. Each year, approximately 170 merit-based scholarships of up to $10,000 (totaling $1,700,000) are offered to deserving students. As the recipient of a Town and Gown scholarship, Annie demonstrates 

academic strengths, leadership, and community involvement. Currently completing a Master’s degree in Regulatory Science, she has achieved a cumulative graduate GPA of 3.73. Her student-driven research in pediatric representation in clinical trials has been presented at multiple academic and professional conferences such as Drug Information Association, Association for Clinical and Translational Science, American Pharmacists Association, and USC School of Pharmacy’s Moving Targets. She has been active in USC and community organizations such as SplashSC, a student organization focused on providing education catering to the needs of high school students in areas surrounding the USC campus, and the Asia Pacific American Mentorship Program, and the Community Health Involvement Project (CHIP).

Annie is ambitious and career-oriented and recently completed an internship with Gilead Pharmaceuticals this past summer.

She was honored at the Town and Gown of USC’s annual Back-to-School Luncheon and Scholarship 101 Workshop this past Sunday, August 29, 2021.

Highlight posted on August 30, 2021

The Regulatory Science Research Team’s summer research culminated in the submission of five student presentations to the 2021 Young Investigator Awards. Research team undergraduate and graduate researchers showcased their work and shared their findings via digital media presentations at Moving Targets 2021Moving Targets is an annual multidisciplinary symposium held by the AAPS Student Chapter in the Department of Pharmacology and Pharmaceutical Sciences at the USC School of Pharmacy that fosters interaction between graduate students and leading scientists, innovators, and policymakers from academia, industry, and government.

Recorded presentations can be viewed here. To view student presentation slides please follow the title links below.

Arianna Crovetto; “Consumer Pricing of Antiretroviral Treatment in Los Angeles County: Tensions between Patents and Treatments”
Carly Yang; “Patterns of Exclusion in Antidepressant Clinical Trials”
Janet Wu; “The Impact of COVID-19 Pandemic on Non-COVID-19 Clinical Trials”
Ngoctran Tran; “Assessing the Current Regulatory Framework for Medical Device Cybersecurity”
Nicholas Naumov; “Mapping Clinical Trial Outcome Measures for Atopic Dermatitis”

Highlight posted on August 20, 2021


Mr. Chin-Wei Soo joins the distinguished 2021 class of Regulatory Affairs Professionals Society (RAPS) Fellows. The RAPS Fellows program recognizes senior regulatory professionals for their significant contributions and leadership in advancing the regulatory profession. In addition, RAPS Fellows are an important resource for helping the organization by supporting mentoring efforts, developing strategic directions, implementing special initiatives and advancing RAPS’ international development efforts.

Chin-Wei is the Global Regulatory Head, Combination Products, Devices, and Digital Health at Roche/Genentech. He is accountable to provide technical regulatory oversight to Roche’s entire device, combination product, and digital health portfolio, covering all large Biologics License Applications and small molecules New Drug Applications throughout the product lifecycle. Chin-Wei has built a global regulatory team that secures regulatory approvals for combination products globally.

Congratulations! On behalf of the Department of Regulatory and Quality Sciences, we thank you for your continued dedication and contributions to the regulatory community. Your vision and leadership are recognized and appreciated by your colleagues and the global regulatory profession.

Highlight posted on August 12, 2021


Congratulations to all participants for contributing to the success of DIA 2021 in support of the conference theme: Collaboration without Boundaries pushes beyond walls, beyond borders. Faculty, staff and Research Team students contributed to DIA 2021 held on June 27 to July 1, 2021. Dr. Nancy Pire-Smerkanich, DIA Student Advisor hosted and presented at the Forum on Career Choices. Ms. Kristen Felthousen provided an interactive professional resume workshop introducing students to the fundamentals of resume/CV writing skills. Ten Research Team student submitted ePosters featured in an online gallery throughout the duration of virtual meeting. To view the students’ research please follow the ePoster title links below.

Annie Ly: “Inclusion of Pediatric Participants in Clinical Trials: Which Regulatory Process if Better, BPCA or NDA?”

Carly Yang: “Patterns of Exclusion – Antidepressant Clinical Trial Comorbidities”

Christian Reyes: “Building an Innovative, Comprehensive Plain Language Summary Development Platform”

Emily Donahue: “Barriers to Diabetes Technology in Low-Income Patients”

Erica Lee: “Examining the Scientific and Regulatory Basis of Treatments for Muscle Cramps”

Griffin Riggs: “Youth Nicotine Addiction: Strategic Regulation Defiance by the Disposable Electronic Nicotine Delivery System (ENDS) Industry”

Kelsey Genda: “Regulatory and Compliance Challenges of Dietary Supplements in the Areas of Quality and Therapeutic Claims”

Omer Baker: “Review of Government-Sponsored Studies and Food and Drug Administration (FDA) Guidance for COVID-19 Diagnostic Testings”

Stacy Uhm: “Chronically Left Out – Lack of Patient Diversity in Chronic Disease Clinical Trials in Los Angeles”

Tyler Fukunaga: “Is Clinical Trial Design a Barrier to Alzheimer’s Disease Pharmacotherapy Development? An Analysis Based on Drug Class”

Highlight posted on July 6, 2021


For the 2021 academic year, USC awarded 97 students the Order of Troy for their academic excellence while devoting extensive time and energy in service outside the classroom and 113 students the Order of Arête, the highest honor accorded graduate students, for campus or community leadership roles beyond their programs of study.

This year, three Regulatory Science Research Team members are award recipients; Emily Donahue (Order of Troy), Christian Reyes (Order of Arête) and Kelsey Genda (Order of Arête).  Students
like you are our present and our future! This moment is to be celebrated for you are the next generation of thoughtful leaders, innovators and entrepreneurs who will bring positive change for society and the environment.

For your lasting impact on the Research Team; we wish you all the best in your future endeavors.

Emily Donahue
Christian Reyes
Kelsey Genda

Research team students – Annie Ly, Cecilia Nguyen, Christian Reyes, Emily Donahue, Kelsey Genda, and Sunyoung (Stacy) Uhm are USC graduates. Congratulations to you all! Your moment has arrived and your next adventure awaits.

Translational Science 2021  (March 30 – April 2, 2021) transitioned into a virtual experience featuring a scientific program focused on breaking barriers and building bridges across clinical research and translational science. With the pandemic as a backdrop to our daily lives, Research Team students continued to reshape their world and told a thought-provoking story of research topics ranging from pediatric medicine, health access and equity, patient engagement and more! To follow this tale, click the student ePoster title links below.

Annie Ly: “Examining the Impact of BPCA: Promoting Pediatric Inclusion in Clinical Trials and Pediatric-Specific Drug Information”

Christian Reyes: “A Comprehensive Online Platform for Plain Language Summary Development”

Emily Donahue: “Barriers to Diabetes Technology in Low-Income Patients”

Highlight posted on April 3, 2021


Department Chair Dr. Eunjoo Pacifici and Associate Director of Undergraduate Education Dr. Terry Church gave the two-part seminar series, which was developed as a collaborative project between the USC East Asian Studies Center and the Department of Regulatory and Quality Sciences.

The series is titled “Regulatory Science: East Asian Perspectives”.   As developers, manufacturers, and consumers of regulated products, East Asia plays a prominent role in all facets of the area of Regulatory Science. In the first webinar session for the series, they focused on “Drugs in COVID Times” and examined the role of East Asia in global drug development. The second seminar examined Traditional Chinese Medicine (TCM), which is commonly practiced in China and other Asian countries, based on traditions that go back thousands of years. In most Western countries, TCM gets labeled as Complementary Alternative Medicine (CAM) and typically viewed as supplemental to conventional medical practices. Some products are regulated as food or dietary supplements while others are developed as drugs.

Click an image below to watch each video.

Regulatory Science: East Asian PerspectiveTraditional Chinese Medicine as Food

In a March 17, 2021 webinar hosted by the Trial Innovation Network, the University of Southern California Clinical and Translational Science Institute (SC CTSI) and the Georgia Clinical and Translational Science Alliance (Georgia CTSA) presented on ongoing collaboration on an exciting new educational venture geared toward clinical research professionals at every stage of their professional development. The presentation informed attendees about the conceptualization, development and implementation of an online career navigation system designed to support career management efforts of clinical research professionals. Drs. Pacifici, McCauley, Choi and Rojewski presented on details of the ongoing development, including an online course catalog with free trainings and the STELLAR platform.

The archived presentation and accompanying recording are posted on the Trial Innovation Network website.

The informative webinar was well attended and attendees were enthusiastic about the presentations, with a post event survey indicating outstanding satisfaction.

American Pharmacists Association (APhA) Annual Meeting and Exposition, the only conference that brings together the entire pharmacy community, took place virtually on March 12-15, 2021. Through this innovative and creative opportunity, nine USC Regulatory Science Research Team posters were accepted and published. Undaunted by the pandemic, students were quick to pivot to the online platform and utilized digital ePosters and video recordings to bring new meaning to the old term “poster presentation.” To view our student’s research results please follow the ePoster title links below.

Annie Ly: “Who is Afraid of BPCA? Promoting Pediatric Inclusion in Clinical Trials and Pediatric-Specific Drug Information”

Carly Yang: “Antidepressants among Special and Vulnerable Populations: Examining Clinical Trials for Generalizability of Findings”

Cecilia Nguyen: “Representation of Race and Ethnicity in Clinical Trials for Pediatric Mental Health Disorders”

Christian Reyes: “Building a Platform for Developing, Disseminating, and Gathering Feedback on Plain Language Summaries for Clinical Trial Participants”

Emily Donahue: “Barriers to Diabetes Technology in Low-Income Patients”

Erica Lee: “Examining the Scientific and Regulatory Basis of Treatments for Muscle Cramps”

Kelsey Genda: “Quality, Safety and Efficacy Issues of Dietary Supplements”

Omer Baker: “Review of Government-Sponsored Studies and Food and Drug Administration (FDA) Guidance for COVID-19 Diagnostic Testing, Treatments, and Vaccines”

Tyler Fukunaga: “Is the Clinical Trial a Potential Barrier to Alzheimer’s Disease Pharmacotherapy Development?”

For general information on Research Activities, click here.
Highlight posted on March 18, 2021

Join us for our next symposium:

Principles of Global Clinical Research for Medical Devices.

We continue our collaboration with SC CTSI and APEC to bring you our next in-depth symposium.  Our presenters are experts in the field of internationally clinical research for medical devices.

To register, read the bios of our speakers, and to view the agenda, go to the symposium info page.  Free for academia.

We look forward to seeing you on April 9th!

April APEC symposium info graphic USC Int'l Ctr for RegSci/SC CTSI logosAPEC full logo

Clliinical Research Career Pathways

We had a great symposium: “Clinical Research Career Pathways”.  Learn about the many ways you can map a career in the various aspects of clinical research.  Join us for the next one!

Click HERE to view the recordings and materials.

Join us in this virtual event experts from the United States and Taiwan including academic scholars, industrial professionals, and clinical physicians will give comprehensive perspectives on the required regulations with a specific aim to facilitate the collaboration for device development in a holistic manner.


To view the meeting agenda, click here.

To see highlights of all International Activities, click here.
Highlight posted on February 4, 2021


Dr. Clemens recent publications appeared in November 2020 issue of the Journal of Dietary Supplements.

COVID-19 during Pregnancy and Postpartum: Antiviral Spectrum of Maternal Lactoferrin in Fetal and Neonatal Defense
Sreus A. G. Naidu, MS, PharmD, Roger A. Clemens, DrPH, FIFT, CFS, FASN, FACN, CNS, FIAFST, Peter Pressman, MD, MS, FACN, Mehreen Zaigham , BSc, MD, PhD, Kelvin J. A. Davies , PhD, DSc, MAE, FRSC, FRCP, FLS, FRI & A. Satyanarayan Naidu, PhD, FACN, FLS, FISSVD
To view above reference article please click here.

COVID-19 during Pregnancy and Postpartum:
1) Pathobiology of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) at Maternal-Fetal Interface
Sreus A. G. Naidu, MS, PharmD, Roger A. Clemens, DrPH, FIFT, CFS, FASN, FACN, CNS, FIAFSTPeter Pressman, MD, MS, FACN, Mehreen Zaigham, BSc, MD, PhD, Kamran Kadkhoda, PhD, SM(ASCP), D(ABMM), D(ABMLI), Kelvin J. A. Davies, PhD, DSc, MAE, FRSC, FRCP, FLS, FRI & A. Satyanarayan Naidu, PhD, FACN, FLS, FISSVD 
To view above referenced articles please click here.

Highlight posted on November 10, 2020

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates October 2020.

For general information on Education Initiatives, click hereHighlight posted on November 6, 2020


EMA Kicks off Rolling Review of Astra Zeneca COVID Vaccine Candidate

The European Medicines Agency (EMA) human medicines committee (CHMP) has begun a rolling review of the Astra Zeneca/Oxford vaccine candidate, which is based on an engineered chimpanzee adenovirus vector platform called ChAdOx1, because preliminary results from non-clinical and early clinical studies suggest the vaccine triggers the production of antibodies and T cells that target the virus.

FDA Gives Draft Adjuvant Trial Guidance for Renal Cell Carcinoma, Bladder Cancer

Two new draft guidance from the U.S. Food and Drug Administration (FDA) give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers; bladder cancer, and renal cell carcinoma (RCC). “The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer”, said Richard Pazdur, MD, director of the FDA Oncology Center of Excellence.

FDA Seeks Withdrawal of Makena, Generics from Market

The U.S. Food and Drug Administration (FDA) proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a post-market study failed to demonstrate a statistically significant benefit over a placebo in reducing preterm delivery or neonatal morbidity and mortality.

FDA Announces All-Time Low Rates for FY2021 PRVs

The U.S. Food and Drug Administration (FDA) has announced historic low rates for fiscal year 2021 fees to use material threat medical countermeasure (MCM) priority review voucher (PRV) programs.

FDA Issues COVID-19 Vaccine EUA Guidance

The U.S. Food and Drug Administration (FDA) issued final guidance, which explains the statutory criteria for a COVID-19 vaccine emergency use authorization (EUA) and provides recommendations for the regulatory, chemistry, manufacturing and controls (CMC), and safety and effectiveness information, after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.


Stem Cell Clinic Slapped with CBER Warning

A chiropractor who operates a stem cell clinic has received an untitled letter from the U.S. Food and Drug Administration (FDA) for marketing intrathecal and intravenous injection of human stem cell products to treat Parkinson’s disease and diabetes. The Center for Biologics Evaluation and Research (CBER) letter clarifies that lawful marketing of OHSTEMCELL products require that they have biologics licenses, which they do not.

Generic Drug-Makers Get Revised MAPP for Suitability Petitions

The Manual of Policies and Procedures (MAPP) published by the U.S. Food and Drug Administration (FDA) Office of Generic Drugs lays out how applicants can petition to submit an abbreviate new drug application (ANDA) when the generic drug differs from the reference listed drug (RLD) in dosage form or strength, or in its route of administration.

Voyager Takes a Hit after FDA Places Hold on Gene Therapy for Huntington’s Disease

U.S. Food and Drug Administration (FDA) placed a clinical hold on the Voyager Therapeutics Investigational New Drug (IND) application for VY-HTT01 for the treatment of Huntington’s disease until the resolution of specific chemistry, manufacturing and controls (CMC) concerns.

TGA Moves Astra Zeneca’s Vaccine on First Step toward Approval

The Australian Therapeutic Good Administration (TGA) has taken the first step toward provisional approval of the Astra Zeneca/ Oxford vaccine, ChAd0x1-S, against COVID-19. This first step means that Astra Zeneca can now apply for provisional registration in the Australian Register of Therapeutic Goods (ARTG). 


CDER Launches Quality Management Maturity Pilots for APIs and Finished Dosage Forms

The U.S. Food and Drug Administration (FDA) has launched two pilot programs related to manufacturing quality management. One pilot program will characterize quality management maturity (QMM) for finished dosage forms for domestic manufacturers of prescription and over-the-counter (OTC) drug products. The second pilot will look at QMM for active pharmaceutical ingredients (APIs), including drug substance intermediates, from foreign manufacturers destined for use in FDA-regulated prescription and OTC products.

IMDRF Proposes Update on Post Marketing Device Studies

The International Medical Device Regulators Forum (IMDRF) has issued a proposed update to its guidance on post market clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies. The guidance does not apply to in vitro diagnostic devices. The proposal is open for consultation until 11 December 2020.

CHMP: Test All Metformin for Nitrosamines before Release

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) said that, medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market. Nitrosamines have been found at elevated levels in the antacid ranitidine, in certain anti-hypertensive medications and tuberculosis drugs, and in extended release metformin. The substance occurs naturally in minute amounts, but elevated levels may be carcinogenic.

TGA Gives Pfizer COVID Vaccine Provisional Determination

The COVID-19 vaccine candidate, BNT12b2, being developed by Pfizer, has received provisional determination from the Australia Therapeutic Goods Administration (TGA). TGA’s provisional regulatory pathway gives sponsors an accelerated, but still “formal and transparent,” mechanism to speed up registration of medicines and vaccines the agency deems promising, using more preliminary clinical data than would be required for a full approval for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Philippine FDA Posts COVID Trial Guidance

The Philippine Food and Drug Administration (FDA) aims to process clinical trial requests for COVID-19 therapeutics in 30 days and vaccines in 40 days, compared to 60 days under the standard workflow, according to new guidance. The big difference is that the regulatory review stage will take 14 days, compared to 45 days under the standard process.


Remdesivir Receives FDA Approval for COVID-19

The antiviral remdesivir received approval from the U.S. Food and Drug Administration (FDA) on 22 October to treat older children and adults who are hospitalized with COVID-19. The approval of remdesivir was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

FDA Authorizes Restart of the COVID-19 AZD1222 Vaccine U S  Phase III Trial

Clinical trials for the AstraZeneca/Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the U.S., U.K., Brazil and South Africa confirming that it was safe to do so. Based on this evaluation, the U.S. Food and Drug Administration (FDA) authorized the restart in the U.S. after reviewing all safety data from trials globally and concluded it was safe to resume the trial.

EMA Highlights Multiple Considerations When Developing Drugs for Older Adults

The European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling. The document highlights patient acceptability – the ability and willingness to self-administer medication — as a key consideration for older patients.

FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib

The U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to Pfizer’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 years of age and older, as did the European Medicines Agency (EMA). The filings were based on results of a Phase 3 clinical trial, across which abrocitinib demonstrated superior improvements and safety profile.

Dr. Richmond is a member of the program committee for the 2020 APEC pilot Center of Excellence training events organized by Soonchunhyang University in the Republic of Korea, and moderated its first UNTACT event on November 3, 2020.


For more information on APEC Pilot CoRE, email Frances Richmond at fjr(at)
To see highlights of all International Activities, click here.
Highlight posted on November 3, 2020





Nancy Pire-Smerkanich


Kudos to Dr. Smerkanich who now sits on the Editorial Board of the Regulatory Rapporteur. Her very first “assignment” was to co-edit the November 2020 North American edition. In addition to the editorial, Dr. Smerkanich wrote an article, “FDA issues guidance for 2017 final rule on penalties related to database.” Additional articles in the journal editions are an update on FDA modernization activities, a piece on Regulatory Intelligence, and a report on the Regulatory Affairs Professionals Society Combination Products meeting. Please join us in congratulating Dr. Smerkanich; your dedication, enthusiasm and insight are really inspiring!  To view above referenced articles please click here. Highlight posted on October 26, 2020



Join the webinar:  “Drugs in COVID Times webinar”, Wed. Oct. 10, 1pm (PDT)

Free Registration HERE

EASC has launched another new series on Regulatory Science: East Asian Perspectives which represents an exciting collaboration with colleagues at the Health Sciences Campus to cover a wide range of topics on health and wellness that are of vital interest to us today.

In Regulatory Science, we study the regulatory requirements for biomedical products in the United States and elsewhere around the world. East Asia plays a prominent role in all facets of this area — as developers, manufacturers, and consumers of regulated products.

In our first webinar session for the series, we will focus on “Drugs in COVID Times” and examine the role of East Asia in global drug development. USC Professors Eunjoo Pacifici and Terry Church will weave history, current events, and future outlook of the region.

COVID graphic

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates September 2020.

For general information on Education Initiatives, click hereHighlight posted on October 12, 2020


FDA Addresses Nitrosamines in TB Drugs

Rifampin and rifapentine are antibiotics used to treat tuberculosis. Elevated levels of nitrosamines have been found in samples of both drugs and long-term exposure to elevated nitrosamine levels may increase the risk for cancer. The U.S. Food and Drug Administration (FDA) is directing manufacturers whose samples of the antibiotics test above acceptable daily intake levels for nitrosamines to contact the Center for Drug Evaluation and Research Drug Shortage Staff for case-by-case determinations of whether the drugs should be released for distribution.

FDA Updates Deferral Guidance for Blood and Plasma Donation

Revised guidance from the U.S. Food and Drug Administration (FDA) addresses screening for variant Creutzfeldt-Jacob disease (vCJD) as well as other transmissible spongiform encephalopathies for donors of blood and blood products. Donors should not be questioned about these conditions because these diseases are rare and it is not possible to identify those who might have one of these conditions but is asymptomatic.

FDA Issues 36 New and Revised Product-Specific Guidance

The U.S. Food and Drug Administration (FDA) released 19 new and 17 revised draft guidance. The guidance is intended to promote generic competition by clarifying the agency’s expectations for the studies required to demonstrate that a generic drug is equivalent to a reference listed drug.

FDA Releases Draft Guidance on PROs for Device Manufacturers

Device manufacturers have new draft guidance from the U.S. Food and Drug Administration (FDA) for the selection of patient-reported outcome instruments in clinical evaluation of their products. The draft guidance was jointly issued by the Center for Devices and Radiological Health and the Center for Biologics Evaluation and Research. It details such topics as modification or adaptation of existing instruments, and the possibility of nesting patient-reported outcome instruments within real-world data sources.

Warning Letter
FDA warns Mylan, Acella Pharmaceuticals over GMP Violations

U.S. Food and Drug Administration (FDA) investigators found issues with Mylan’s facility in India regarding cleaning procedures and record-keeping for its non-dedicated bulk storage tanks used for numerous active pharmaceutical ingredient (API) manufacturing processes. The warning letter, Acella for its quality unit failure to adequately oversee its contract manufacturing organization and low, out-of-specification results for its NP Thyroid tablets ingredients.


Pharmacovigilance and QPPV: Post-Transition Guidance from MHRA

The U.K Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance detailing post-transition pharmacovigilance procedures and requirements for having a qualified person responsible for pharmacovigilance (QPPV) and a pharmacovigilance system master file (PSMF) for U.K. authorized products, including U.K. and non-U.K. individual case safety reports (ICSRs), periodic safety update reports (PSURs), risk management plans (RPMs) and post-authorization safety studies (PASS) protocols and final study reports.

COVID-19 Therapeutics Tracker

The search is on for researchers and manufacturers to find treatment candidates that lower mortality rates and lessen the severity of COVID-19. Convalescent plasma has been granted an emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for patients hospitalized with suspected or laboratory-confirmed COVID-19.

EMA Recommends Pulling Ulipristal Acetate for Fibroids

Citing the possibility of serious liver injury from ulipristal acetate, the European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) recommended the revocation of marketing authority for 5mg oral tablets, which are marketed as Esmya and generics. The medication, to treat moderate to severe symptoms of uterine fibroids, is to be used for up to three months before surgery or for long-term use with intervals of treatment cessation.

Medical Device
FDA Qualifies Decision Tool for Breast Reconstruction Studies

The BREAST-Q Reconstruction Module is now qualified as a medical device development tool (MDDT) to aid sponsors and investigators in developing feasibility, pivotal and post-approval studies of medical devices used in breast reconstruction. The tool includes several scales and aims to quantify the patient’s quality of life and satisfaction with breast reconstruction surgery and to monitor and address serious side effects associated with silicone breast implants.

Warning Letter
FDA Warns Firm: Test batches before, not after release

An Indonesian firm was warned by the U.S. Food and Drug Administration (FDA) for failures in product testing and method validation, among other breaches of current good manufacturing practice (cGMP). The firm used an assay testing method for the active ingredient in the finished product that was not a US Pharmacopeia (USP) method, nor was it validated by high-performance liquid chromatography.


AstraZeneca Oxford SARS-CoV-2 Vaccine, AZD1222, COVID-19 Vaccine Trials Temporary Pause and Restart

AstraZeneca is conducting a global, randomized, controlled clinical trial of the coronavirus vaccine, AZD1222. Sponsors voluntarily paused all trials and asked an independent committee to review the safety data of a single event of an unexplained illness that occurred in the U.K. Phase III trial. The trials resumed after confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

Coronavirus (COVID-19) Update: FDA Publishes Comparative Performance Data for COVID-19 Molecular Diagnostic Tests

The U.S. Food and Drug Administration (FDA) published comparative performance data for some authorized COVID-19 molecular diagnostic tests. The data show the Limit of Detection (LoD) of more than 55 authorized molecular diagnostic COVID-19 tests against a standardized sample panel. Test developers who are required to assess their test’s performance against standardized sample  panel as a condition of their Emergency Use Authorization (EUA).

Warning Letter
FDA Warns Website Operators Illegally Selling Opioids to Consumers

The U.S. Food and Drug Administration (FDA) has issued warning letters to 17 website operators for illegally selling unapproved and misbranded opioids, such as tramadol and oxycodone, online in violation of the Federal Food, Drug, and Cosmetic Act. Misbranded opioids include those offered for sale without a prescription, as well as opioids that lack adequate directions for use.


FDA Releases Guidance on Inclusion of Geriatric Information in Drug Labeling

The U.S. Food and Drug Administration (FDA) revised guidance geriatric information in drug labeling replaces the October 2001 guidance document – “Content and Format for Geriatric Labeling”. Drug sponsors must include geriatric information in their label when there is sufficient information to detect an efficacy and/or safety differences between younger adult patients and geriatric patients.

EMA Backs Dexamethasone for COVID-19, Seven New Medications and Consults on ICH Q3D Guideline

The European Medicines Agency (EMA) endorsed the use of dexamethasone to treat COVID-19 patients who are on oxygen or mechanical ventilation based on results from the RECOVERY trial. Also, EMA began a three-month publication consultation on The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3D(R2) guidelines on elemental impurities which provide permitted daily exposure (PDE) levels for elemental impurities for medicines administered via cutaneous and transdermal routes.


HHS Opens Pathway to Importing Canadian Drugs

The U.S. Department of Health and Human Services (HHS) has issued a final rule that clears a path for the import of some Canadian drugs into the U.S. Some of the most expensive prescription therapeutics on the market, biological products, and some types of prescription drugs are excluded. The final rule can be rescinded if the U.S. Food and Drug Administration (FDA) finds that monitoring the Section 804 Importation Program (SIP) is too burdensome, or if the program does not lower drug costs. 

Breast Implant Label Guidance Finalized by FDA

The U.S. Food and Drug Administration (FDA) issued guidance  to clarify the relationship between implants and systemic disease, language to improve the readability of the patient device card, and information on specific registries to track real-world data on breast implants. It is important that patients discuss the risks and benefits of breast implants with their health care provider and the aim is that these labeling recommendations will help in facilitating these discussions.

FDA Finalizes Blood Glucose Monitor Guidances

The U.S. Food and Drug Administration (FDA) finalized guidance providing recommendations for device makers looking to submit 510(k)s for prescription point-of-care and over-the-counter blood glucose monitoring systems (BGMSs), focusing on reducing the risk of bloodborne pathogen transmission, device description and performance evaluation to support 510(k) submission, as well as recommendations for test strips, software and labeling for their respective devices.

Generic Drugmakers Get Guidance on Tentative Approvals, CRLs

The U.S. Food and Drug Administration (FDA) issued guidance designed to boost the number of affordable generics on the market by helping applicants avoid delays on the path to final approval. The guidance addressing complete response letter (CRL) responses should help streamline the abbreviated new drug application (ANDA) process.

Join us for our next live virtual Symposium!

Our virtual events have been very interesting, very informative, and very interactive!

Go HERE to register and for more information.

Diversity in Clinical Trials symposium title bar

The Regulatory Knowledge and Support (RKS) core group from the Southern California Clinical and Translational Science Institute (SC CTSI) has partnered with colleagues from the Georgia Clinical and Translational Science Alliance (CTSA) Translational Workforce Development (TWD) to develop a course catalog of trainings and educational offering aimed at clinical research professions at every stage of their professional development.

Since Spring 2020, the RKS core group of Dr. Eunjoo Pacifici (Director), Dr. Nancy Pire-Smerkanich (Associate Director), Yu Chung and Apurva Uniyal (Project Administrators) have contributed to the Self-career Training, Education, Life-long Learning Advancement Resource (STELLAR) program by building training course catalogs that is at the core of this initiative. Currently still in development, the STELLAR program initiative aims to systematically address a need for education and support for the entire clinical and translational research workforce, beyond formally trained faculty, trainees and fellows. The free online system is a navigational tool to guide training and skills development for various segments of the clinical and translational science workforce.

To view the letter for the course catalog click here. For more details about the launch click here.

For general information on Education Initiatives, click here.
Highlight posted on September 11, 2020

Moving Targets is an annual multidisciplinary symposium held by the American Association of Pharmaceutical Scientists (AAPS) Student Chapter in the Department of Pharmacology and Pharmaceutical Sciences at the USC School of PharmacyUnthwarted by the COVID-19 pandemic, AAPS organizers transformed the once in-person symposium into a Young Investigator Awards, a virtual research poster competition showcasing student driven research. In the same spirit, AAPS released a weekly Moving Targets Newsletter with information on weekly seminars, faculty spotlights, and news in immunopharmaceutics.

Our own regulatory science faculty has been featured in recent newsletters! Check out how Dr. Nancy Pire-Smerkanich (Vol.1) and Dr. Eunjoo Pacifici (Vol.3) continue to teach, mentor, and overcome challenges during these virtual times.

For general information on Research Activities, click here.
Highlight posted on September 8, 2020

In this unprecedented moment in global health, conversations and connections matter more than ever. Journal Club meetings are now in a digital platform to make sure conversations and networking are taking place as much as possible in the new, mostly online world.

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates August 2020. For general information on Education Initiatives, click hereHighlight posted on August 31, 2020


New MAPP Details when FDA Notifies Drugmakers about ARIA Studies

The newly released Manual of Policies and Procedures (MAPP) includes two tables detailing the US Food and Drug Administration (FDA) Center for Drug Evaluation and Research  applicant notification process in the preapproval and post-market phase and provides details on the responsibilities and internal procedures for communicating with applicants regarding Active Risk Identification and Analysis (ARIA) assessments and results.

Draft AML Guidance Takes Targeted Therapies into Account

The US Food and Drug Administration (FDA)draft guidance represents an updated approach to clinical trial design and regulatory submissions for developers of drugs and biologics to treat acute myeloid leukemia (AML), offering several points regarding trial design, specific population, adverse events and the definition of a variety of efficacy endpoints.

Medical Devices
FDA Lists Medical Devices in Shortage under CARES Authority

The US Food and Drug Administration (FDA) published a shortage list based on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The list includes entries for devices under twenty different product codes and various types of personal protection equipment, testing supplies and equipment and ventilation-related products, but does not mention the specific devices or names of manufacturers.

FDA Finalizes First Device-Specific Safety and Performance Based Pathway Guidance

The US Food and Drug Administration (FDA) established performance criteria to support 510(k) clearance via a new pathway for two device-specific guidance (cutaneous electrodes for recording purposes and conventional foley catheters). The FDA indicated the new optional safety and performance-based pathway builds on its abbreviated 510(k) program to give device makers the flexibility to use performance criteria and voluntary consensus standards rather than direct comparison testing against a predicate device to support 510(k) clearance.

Clinical Trials
Penalty Policy for Trial Reporting Violations Finalized

New guidance details how the US Food and Drug Administration (FDA) plans to identify if responsible parties have failed to submit required clinical trial registration or results to the data bank, or if parties have falsified data or filed misleading information, or failed to submit certification to FDA. The determination to seek civil money penalties will hinge in part on whether the responsible party has taken corrective action within the 30-day mark after receiving a Notice of Noncompliance.

Quality Systems
MHRA Looks to Restart Onsite Inspections

Beginning in September, The UK Medicines and Healthcare products Regulatory Agency (MHRA) will resume on-site, risk-based GxP inspections. MHRA will continue to use remote inspection approaches alongside in-person activities as the UK eases COVID-19 restrictions and will work to scale up to a full inspection program by October, 2020.


ANDA Consolidation Process Updated in New MAPP

The US Food and Drug Administration (FDA) Center for Drug Evaluation and Research revised manual of policies and procedures (MAPP) provides an updated workflow for the consolidation review process under the Abbreviated New Drug Application (ANDA) Consolidation Coordinator at the Office of Generic Drugs (OGD). The MAPP revisions clarify the process for sponsors who wish to consolidate several ANDAs for different strengths of the same drug into a single “parent” ANDA. Which ANDA becomes the parent is generally determined by which drug product strength was used for bioequivalence studies.

Health Canada Adopts ICH Pediatric Drug Development Guidance

Health Canada is fully implementing guidance S11: Nonclinical Safety Testing in Support of Development of Pediatric Medicines, developed by the International Council for Harmonization of Technical Requirements of Pharmaceuticals for Human Use (ICH), without modifications.

Medical Devices
European Commission Sets Common Specifications for Reprocessing Single-Use Devices

Under the EU Medical Device Regulation (MDR), single-use devices may be reprocessed where permitted by national law. The regulation adds a requirement for health institutions to copy serious incident reports to the original manufacturer and where applicable the external reprocessor. Additionally, the regulations no longer call for the tracking system to record which patients reprocessed single-use devices.

FDA Revokes Umbrella EUA for Some Patient Barrier Enclosures

The US Food and Drug Administration (FDA) revoked the umbrella emergency use authorization (EUA) it had previously issued for passive, non-negative pressure protective barrier enclosures that are intended to be a physical barrier preventing healthcare provider exposure to airborne pathogens. The EUA was revoked due to preliminary evidence in simulated intubation procedure models of potential adverse events that could occur or complications with protective barrier enclosures without negative pressure recently reported in the literature.

Quality System
EMA Goes All-Virtual for Remainder of 2020

The EU European Medicines Agency (EMA) has announced that all its committee and working party meetings will be held virtually through the end of 2020 to reduce the further spread of COVID-19.

FDA Issues Pandemic Inspections FAQ Guidance

The US Food and Drug Administration (FDA) issued frequently asked questions guidance explaining its approach to inspections and manufacturing and supply chain changes during the coronavirus disease (COVID-19) pandemic. The FAQ takes effect immediately. The FDA will continue to resume domestic inspections and postpone non-mission-critical foreign pre-approval and for-cause inspections. On the other hand, companies should reach out to the responsible office to discuss atypical or flexible submission strategies for changes of manufacturing and supply chain.

Moving Targets is an annual multidisciplinary symposium held by the AAPS Student Chapter in the Department of Pharmacology and Pharmaceutical Sciences at the USC School of Pharmacy. The Moving Targets seminar series fosters interaction between graduate students and leading scientists, innovators, and policymakers from academia, industry, and government. For Moving Targets 2020, of the 19 posters published from the symposium, 11 posters were from students of the Regulatory Science Research Team. Our Summer Research Team embarked on a voyage of learning, worked tirelessly, and contributed to a successful Moving Targets 2020, undaunted by the Covid-19 emergencyTo get to know our students and their research please follow the poster title links below. Student presentations can be viewed here.

Alice Chang presented on“Comparison of Clinical Trials for Spinal-Bulbar Muscular Atrophy (SBMA) between the US and EU, 2000-2019” 

Annie Ly presented on “Examination of FDA Pediatric Regulations: Inclusion of Pediatric Participants in Clinical Trials (2016-2018)”

Cecilia Nguyen presented on “Representation of Children and Adolescents in Clinical Trials for Anxiety and Depression Treatments”

Christian Reyes presented on “What Makes a Plain Language Summary: How Industry Sponsors are Communicating with Participants Post-Trial”

Emily Donahue presented on “Barriers to Diabetes Technology in Low-Income Patients”

Karen Chan presented on “Utilization of Wearables and Trends in mHealth in Current Clinical Research of Neurologic Conditions”

Kelsey Genda presented on “Quality and Safety Issues Surrounding Dietary Supplements”

Michael Seung and Alan Thang presented on “The Impact of COVID-19 on the U.S. Pharmaceutical Clinical Trial Landscape: A Cross-Sectional Analysis of Data”

Omer Baker presented on “Review of Government-Sponsored Studies and Food and Drug Administration (FDA) Guidance for COVID-19 Diagnostic Testing, Treatments, and Vaccines”

Sunyoung (Stacy) Uhm presented on“Inclusion of Diabetic Populations in Clinical Trials Conducted in Los Angeles County”

Tyler Fukunaga presented on “Is the Clinical Trial a Potential Barrier to Alzheimer’s Disease Pharmacotherapy Development?”

For general information on Research Activities, click here.
Highlight posted on August 29, 2020

The Drug Information Association (DIA) 2020 Global Annual Meeting, designated “Patients Included” reflects DIA’s commitment to incorporating the experience of patients as experts in living with their condition while ensuring they are neither excluded nor exploited. Students from the USC Department of Regulatory Science Research Team are integrated with DIA’s overarching event goals as reflected in the work of Annie Ly, Christian Reyes, and Karen Chan who submitted digital abstracts and posters for DIA 2020.

Annie Ly’s work “Examination of FDA Pediatric Regulations: Inclusion of Pediatric Participants in Clinical Trials” examines the extent to which current FDA policies have impacted pediatric enrollment into clinical trials wherein proper dosage and labeling of medication for the pediatric population remains a serious public health challenge. Results illustrate the challenges and opportunities faced around the world for development of pediatric medications (including drugs used only by pediatrics or pediatrics and adults) that are plagued by small sample sizes, invalidated clinical endpoints, and limited studies. Please click here for Annie Ly’s handout.

Christian Reyes’ research “Plain Language Clinical Trial Result Summaries: Are Participants Getting it?” focuses on information presented to study participants must be patient-centered, free of jargon, understandable, non-technical and prepared in plain language. This initiative hopes to facilitate comprehensive and accessible information to the populations we study. Please click here for Christian Reyes’ handout.

Karen Chan’s work on “Utilization of Wearables and Trends in mHealth in current clinical research of neurologic conditions” delves deeper into healthcare aspects of the cloud as it increasingly shapes every aspect of clinical trials, including patient recruitment, data analytics, monitoring, and the extent that remote trials without site visits by patients are a real possibility. Please click here for Karen Chan’s handout.

Our student driven Research Team is mobilized across the life sciences to engage patients, peers and mentors on the issues of today and the possibilities for tomorrow.

Highlight posted on June 15, 2020

We are delighted to announce that Dr. Nancy Pire-Smerkanich has been selected to receive the 2020 Drug Information Association (DIA) Inspire Award for Excellence in Service in the Americas Region.  This award is given in recognition of those who have provided outstanding contributions to advancing global health with volunteer service awards that honor exceptional leadership, commitment to service, and advancement of DIA’s mission.

Dr. Pire-Smerkanich, DRSc, is an Assistant Professor, Department of Regulatory and Quality Sciences in the School of Pharmacy at the University of Southern California. In addition to teaching courses related to drug development and clinical trials, Dr. Pire-Smerkanich provides regulatory guidance to industry peers and serves as a faculty mentor for our undergraduate research team. Known for her dedication to education and mentoring across industry, Dr. Pire-Smerkanich continues to be recognized for her ability to provide accurate, relevant and dynamic instruction on both technical and strategic aspects of global regulatory affairs and for her service to professional organizations such as DIA and The Organization for Professionals in Regulatory Affairs.  Her passion and enthusiasm for medical regulation make her classes memorable due to creative scenarios she has students engage in.  She brings that same vigor to her mentorship and among the students and is a highly sought-after faculty member.  Her laugh is warm, inviting, and boisterous.

Heart-felt thoughts from Dr. Pire-Smerkanich:
“It has been my privilege for the last 30+ years to serve the DIA community and my peers as well as our students and young professionals. It is I who have been inspired by the integrity of the people and work we do in academia, industry and government to advance healthcare product development.”

We would like to extend our congratulations to Dr. Pire-Smerkanich for this well-deserved recognition!

Highlight posted on June 4, 2020

Pooja Singh, #2020trojans, graduates today with a major in Pharmacology and Drug Development. While it is not the graduation any of us had in mind, her virtual graduation comes with added joy. Alongside the awarding of two bachelor’s degrees, Pooja has earned a number of very prestigious accolades that are some of the most prominent designations an undergraduate could be given at graduation. Pooja has been named a Renaissance Scholar which recognizes undergraduate students who have excelled in their studies while completing a major and two minors (Business Finance and Natural Science) in widely separated fields of study, a Discovery Scholar (and prize!) which recognizes undergraduate students who have excelled in their studies while demonstrating an ability to create exceptional new scholarship or artistic works, and the Order of Troy, awarded to those who have distinguished themselves beyond their peers in at least one facet of university life and have made notable contributions to the university community as active leaders or critical contributors in service to peers, the university community or the world at large.

Pooja utilized scholastic achievement, research interests, and her unique imagination to truly flourish as a student at USC.  She has demonstrated outstanding scholarship, creativity in research, and great leadership skills.  Her professors agreed that Pooja was the kind of student who asked thoughtful questions, participated in discussions frequently, and had an eagerness to learn new things.  Simply, Pooja embodies the best qualities of undergraduate scholarship.  Congratulations Pooja and best of luck pursuing a PharmD degree at USC and in all future endeavors!  Fight on!

Highlight posted on May 15, 2020

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates April 2020. For general information on Education Initiatives, click hereHighlight posted on May 8th, 2020


NICE Backs Bayer’s Vitrakvi for NHS Use

The U.K. National Institute for Health and Care Excellence (NICE) reported that the results from trials suggest that neurotrophic tyrosine receptor kinase (NTRK) gene fusions shrink in response to Vitrakvi (larotrectinib) but that it is not clear how well the drug works compared with other treatments. For this reason, the institute recommended against the drug, finding that it was not cost-effective at the price.

Coronavirus Disease 2019 (COVID-19) 
The FDA Seeks to Expand Use of Remote Digital Pathology Devices amid Pandemic

The U.S. Food and Drug Administration (FDA) issued a temporary enforcement policy easing regulatory requirements for some Class II digital pathology devices to expand the availability of remote reviewing and reporting of pathology slides amid the coronavirus disease (COVID-19) pandemic. Under this policy, companies do not need to comply with good manufacturing practice (GMP) or unique device identification (UDI) requirements, or special controls typically applied to such devices, but they need to adhere to labeling and performance requirements in order to modify, or market, devices in line with the policy.

Hydroxychloroquine Falls Flat as COVID-19 Treatment

An expert panel of the U.S. National Institutes of Health (NIH) has recommended against the use of hydroxychloroquine with antibiotic azithromycin outside of clinical trials for COVID-19 treatments because of potential toxicity and increased risk of heart problems. Additionally, the panel did not make any recommendation on the use of hydroxychloroquine or chloroquine alone, citing insufficient evidence.

FDA Reviews Likely to Slow as COVID-19 Workload Increases

The U.S. Food and Drug Administration (FDA) is meeting its user fee-related review goals for now during the COVID-19 outbreak, but the agency may not be able to sustain its current workload. The agency is also working at full capacity to ensure that drug programs continue to see minimal interruptions, but it will need to prioritize if there is an increase in drug shortages or supply disruptions. 

FDA and China NMPA Expedite COVID-19 Emergency Approvals

The U.S. Food and Drug Administration (FDA) and China National Medical Products Administration (NMPA) have moved to fast-track the review of products that might be used to prevent or treat COVID-19. NMPA has issued more than 70 emergency approvals, including several diagnostic tests. The FDA has issued multiple Emergency Use Authorizations (EUAs) for critically important products, including ventilators, respirators and personal protective equipment (PPE) for healthcare providers.


FDA Approves First New Drug under Project Orbis​

Project Orbis is a collaborative review effort for oncology products that includes the U.S. Food and Drug Administration (FDA), Australia Therapeutic Goods Administration (TGA), Health Canada, Singapore Health Sciences Authority (HSA) and Swissmedic.​ Seattle Genetics’ Tukysa (tucatinib) is the first new drug approved by the FDA under Project Orbis. It marks the third action taken by the agency as part of the collaboration and the first time HSA and Swissmedic participated in a review.​ 

Coronavirus Disease 2019 (COVID-19)
COVID-19: FDA, EMA and 16 Drugmakers Take Part in Development Effort

The goal of the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership is to develop a coordinated research strategy to prioritize drug and vaccine candidates and coordinate clinical trials and regulatory processes.​ Focus areas include standardizing and sharing preclinical evaluation methods; prioritizing and accelerating clinical evaluation; maximizing clinical trial capacity and effectiveness, and advancing vaccine development.​

Reagan-Udall Foundation Launches COVID-19 Treatment Hub

The Reagan-Udall Foundation has expanded its Expanded Access Navigator, which facilitates pre-approval access to drugs to launch a COVID-19 “treatment hub” aimed at helping patients and healthcare providers find treatment resources.​ The hub includes a searchable directory of companies developing treatments and a listing of clinical trials and expanded access programs from​

User Fee-Related Reviews on Schedule amid COVID-19

The U.S. Food and Drug Administration (FDA) user fee funded reviews of drugs, biologics and medical devices are progressing according to schedule despite the disruption caused by the coronavirus disease (COVID-19) pandemic. The agency has extended response due dates by 90 days for 510(k)s, premarket approval applications (PMAs), humanitarian device exemptions (HDEs) and De Novo classification requests, which could impact the agency’s ability to meet its goals for total time to decision under its Medical Device User Fee Amendments commitments.​


Coronavirus Disease 2019 (COVID-19)
Regulators Urge RCTs with Control Arms for COVID-19 Drug Trials

The International Coalition of Medicines Regulatory Authorities (ICMRA) meeting summary report stressed the need for COVID-19 drug developers to include an appropriate control arm (i.e. not including antivirals or immune modulators). Regulators expressed concern due to the multitude of ongoing trials and access programs, which may lead to shortages of investigational products, and recommended this to be carefully monitored.

FDA, EC Offer Guidance on COVID-19 Convalescent Plasma

The U.S. Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19. The guidance provides recommendations and information to health care providers and investigators on the administration and study of the plasma.

EMA Q&A Explains Regulatory Expectations for Drugs during the Pandemic

The European Medicines Agency (EMA) and European Commission (EC) released a question and answer (Q&A) document on regulatory expectations for marketing authorization holders (MAHs) and medicines during the COVID-19 pandemic. As far as marketing a medicine in the absence of an authorization, the Q&A indicates that member states can resort to compassionate use, or authorization of the distribution of an unauthorized medicinal product. The Q&A also states that MAHs can request an exemption due to exceptional circumstances and on public health grounds to renew marketing authorizations.

WHO Favors COVID-19 Intellectual Property Pool

The World Health Organization (WHO) aims to enable governments, industry, universities and nonprofits to work together to help develop COVID-19 drugs under the banner of the WHO. The idea was introduced by Costa Rican officials who feared that some COVID-19 products, once developed, would not be made available to poorer nations. 

FDA Grants First EUA for Blood Purification Device for COVID-19 Patients

The U.S. Food and Drug Administration (FDA) granted its first emergency use authorization (EUA) for a blood purification system, the Spectra Optia Apheresis System and Depuro D2000 Adsorption Cartridge devices, to treat patients at risk for respiratory failure due to coronavirus disease (COVID-19). Specifically, the EUA specifies the devices should only be used for patients with early acute lung injury, early acute respiratory distress syndrome or other specific severe or life-threatening symptoms or conditions.


Coronavirus Disease 2019 (COVID-19)
FDA Issues First EUA for Coronavirus Serology Test

The U.S. Food and Drug Administration (FDA) provided the first Emergency Use Authorization (EUA) for a serology test to North Carolina-based Cellex Inc. The test can detect SARS-CoV-2 antibodies, immunoglobulin M (IgM) and immunoglobulin G (IgG) generated as part of the human immune response to the virus. Although the FDA recommends that results from serology testing should not be used as the sole basis to diagnose or exclude a coronavirus infection, the test can help detect how many people have had SARS-CoV-2, even if they did not show symptoms.

FDA Creates Coronavirus Treatment Acceleration Program

The U.S. Food and Drug Administration (FDA) launched the Coronavirus Treatment Acceleration Program (CTAP), an emergency program for potential COVID-19 therapies. Currently, the agency is monitoring 10 therapies in active trials and 15 others in planning stages.

Clinical Trials during COVID-19: Updates from FDA, MHRA and TGA

The U.S. Food and Drug Administration (FDA) updated guidance features for a new appendix offering instructions of clinical trials management, protocol deviations and amendments handling, and submission of formal amendments or supplements for trials conducted under investigational new drug (IND) application or investigational device exemption (IDE) amid the pandemic. The guidance also provides recommendations for handling home delivery of investigational products; considerations for switching from facility to home infusion; delays in on-site monitoring; and obtaining signed informed consent for patients who are in isolation due to COVID-19.

The U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) has written to sponsors conducting Phase I clinical trials to confirm they have conducted a risk assessment for the potential impact of COVID-19 on their studies. MHRA expects that some trials “may be temporarily halted or terminated,” while others may continue if “clearly justified.” The Australia Therapeutic Goods Administration (TGA) posted a clarification about when clinical studies may proceed in relation to its clinical trial notification (CTN) scheme and explained situations where sponsors do not need to notify the agency of variations to their studies due to COVID-19.

FDA Reports Shortage of Sedation Drug Used for Putting COVID-19 Patients on Ventilators

The U.S. Food and Drug Administration (FDA) updated its list of drugs in shortage to include the sedation drug midazolam, which along with other sedatives is being used to treat COVID-19 patients requiring mechanical ventilation. In addition to the sedatives, the unproven but potential COVID-19 treatment hydroxychloroquine sulfate is also listed as currently in shortage.

EMA Advises on Compassionate Use Programs for Remdesivir

The European Medicines Agency (EMA) released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials. EMA explained how to use remdesivir and give preliminary information on its safety in addition to describing which patients may benefit from the medicine.

European Commission Proposes to Delay MDR by a Year Due to COVID-19

With an eye toward avoiding the disruption of the device market at such a critical time, the European Commission (EC) year-long delay will not alter the substance of the Medical Device Regulation (MDR). The delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation,” the EC said.

FDA Relaxes Rules for Infusion Pumps, Clinical Thermometers

The U.S. Food and Drug Administration (FDA) released new guidance for infusion pumps and clinical thermometers in an effort to increase availability of the devices amid the coronavirus disease (COVID-19) pandemic. The enforcement policy for infusion pumps applies to devices under four different product codes and more than 20 different types of accessories that are used with infusion pumps. To increase the availability of clinical electronic thermometers, the FDA will not object to the distribution or use of certain non-510(k) cleared devices.

India Lifts Ban of Hydroxychloroquine Exports

The Indian government said that it will lift a newly imposed export restriction on the anti-malaria drug hydroxychloroquine, a potential COVID-19 treatment. Physicians are now allowed to prescribe the drug to COVID-19 patients under an emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA), but at least 20 states have imposed restrictions and there are serious concerns about possible adverse reactions.


Coronavirus Disease 2019 (COVID-19)
New FDA Program to Accelerate Coronavirus Treatments

The U.S. Food and Drug Administration (FDA) detailed a new “special emergency program”, coronavirus treatment acceleration program (CTAP), for accelerating research and development of potential treatments for coronavirus disease (COVID-19). The FDA intends to respond to developers within a day and will try to conduct trial protocol reviews in some cases within 24 hours. The FDA will also work closely with applicants and other regulatory agencies to expedite quality assessments for products to treat COVID-19 and to transfer manufacturing to alternative or new sites to avoid supply disruption.

DOJ Targets Fake COVID-19 Vaccine Kit Website

The Department of Justice (DOJ) has taken its first enforcement action for fraud related to COVID-19 vaccine kits. The DOJ sued NameCheap, the operator  of the website in a Texas federal court for offering access to “free” World Health Organization vaccine kits in exchange for a shipping charge. U.S. District Judge Robert Pitman issued a restraining order blocking public access to the website.

Notifying FDA of Drug Shortages during the Pandemic: FDA Offers Guidance

The U.S. Food and Drug Administration (FDA) published new guidance on how manufacturers should notify the FDA of permanent halts or interruptions to manufacturing certain products that are likely to lead to a meaningful disruption in supply. Companies should submit notifications no later than five business days after the discontinuance or interruption occurs and update every two weeks, including information on the expected timeline for recovery. FDA staff also have been proactively reaching out to manufacturers to identify potential disruptions or shortages of drugs.

FDA Authorizes Use of New Two-Minute Test Kit for Coronavirus

The U.S. Food and Drug Administration (FDA) has authorized the emergency use of Bodysphere Inc.’s test that can detect the coronavirus in nearly two minutes. The test is administered like a glucose test but is designed for use strictly by medical professionals.

FDA Warns Irish Company for Marketing Unapproved COVID-19 Treatments

As there are still no approved treatments for COVID-19, the U.S. Food and Drug Administration (FDA) warned Ireland-based Carahealth for offering unapproved herbal products and other products referred to as “Immune Tonic” on its website to mitigate, prevent, treat, diagnose or cure COVID-19. The FDA points to dubious claims on the company’s website, such as, “Constituents in herbs exhibit a diverse array of anti-viral, virostatic, immune enhancing and anti-influenza activities that may prevent and treat pandemic influenza.”

Ford, GM, GE to produce 50,000 ventilators in 100 days

Ford said the simplified ventilator design, which is licensed by GE Healthcare from Florida-based Airon Corp and has been cleared by the U.S. Food and Drug Administration (FDA), can meet the needs of most COVID-19 patients and relies on air pressure without the need for electricity. GM said it plans to produce up to 10,000 ventilators a month by this summer at a plant in Kokomo, Indiana.

FDA Warns Pfizer Manufacturing Site in India

The U.S. Food and Drug Administration (FDA) sent a warning letter to Pfizer’s injectable product manufacturing site in Visakhapatnam, India after an inspection. The letter explains how the site did not adequately investigate root causes and implement corrective and preventive action (CAPA) to address deficiencies with its sterility testing. In a follow-up to the warning, the FDA asked Pfizer to provide an assessment and remediation plan for its CAPA program, a complete assessment of documentation systems used throughout the site’s manufacturing plant and laboratory.

FDA Issues and Expands EUA for Respirator Decontamination System

The U.S. Food and Drug Administration (FDA) gave emergency approval to the first system for decontaminating respirators to extend their use amid the coronavirus disease (COVID-19) pandemic, before expanding the terms of the authorization. The emergency use authorization (EUA) initially limited the number of respirators that could be decontaminated using the system to 10,000 per day. After receiving requests from industry, FDA reissued the EUA without a cap on how many respirators the system can process per day. The EUA retains a limit of 20 decontamination cycles per respirator.

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on May 4th, 2020

Clinical Trials
Government Normalizes Clinical Research Related to Coronavirus

Since the outbreak of the novel coronavirus, many clinical research institutions have actively implemented relevant clinical research and found a series of drugs that have significant therapeutic effects against coronavirus, such as chloroquine and tocilizumab. According to the China Clinical Registration Center, as of 4 April, 2020, as many as 567 clinical cases have been conducted. Recently, the Ministry of Science and Technology issued new guidance in terms of clinical research for coronavirus. Clinical research should be subject to the review and approval system for specific medical institutions. Within three days, clinical research should be filed with the health administrative department that issues its medical institution license. For clinical research that has been carried out (the first subject has been enrolled) but has not been completed, the medical institution should complete the work of project establishment, registration and uploading information, within three working days from the date of the new guidance. Medical institutions that have not completed studies within the time limit shall stop the clinical research work.

Medical Devices
NMPA Seeks to Ensure Quality of Exports as China Becomes Key Supplier of COVID-19 Devices

China is stepping up efforts to ensure the safety and quality of exported medical devices. The actions come as countries around the world look to China for equipment for use in the detection, prevention and treatment of the pandemic coronavirus. The reliance on China provides the country with an opportunity to enhance, its reputation as a supplier of medical devices. Quality problems with medical devices shipped from China could cause lasting harm to the country’s reputation. Chinese officials want to avoid that outcome. To do so, the China National Medical Products Administration (NMPA) held a video and telephone conference to discuss monitoring of the quality of medical device exports. NMPA wants staffers to strictly implement requirements on the review and approval of medical devices, which the agency has overhauled in recent years to raise the standard of products sold in the country. In geographic regions with high concentrations of exporters, NMPA plans to bring together people from different departments involved in the oversight of medical technology manufacturers to form a joint supervision group.

China’s CDE Shares Draft Advice on Avastin, Herceptin and Xgeva Biosimilars

The China Center for Drug Evaluation (CDE) has published draft guidance on the clinical development of biosimilar copies of Avastin (bevacizumab), Herceptin (trastuzumab) and Xgeva (denosumab). The flurry of biosimilar documents comes shortly after CDE shared draft guidance for developers of off-patent versions of AbbVie’s Humira (adalimumab). The newly released documents apply the format of the Humira guidance to Roche’s Avastin and Herceptin and Amgen’s Xgeva. All of the drugs are blockbusters, although the arrival of biosimilar competitors has started to affect sales of some of the products in some markets. To support companies that want to challenge Amgen and Roche in China, CDE has created guides for generating data to show off-patent copies are similar, safe, efficacious and compliant with drug quality standards. The guidelines feature details about the trial designs, study populations and doses companies should use to gather the evidence needed to support approval in China. CDE is accepting feedback on the draft guidance for the next month.

Remdesivir Study in Chinese Patients with Severe Symptoms was Stopped Due to Stalled Enrollment

Recently, the New England Journal of Medicine (NEJM) published an analysis of the effect of Remdesivir on COVID-19 who received treatment through the compassionate use program, which is for critically ill patients who are unable to take part in a clinical trial. The results, which cover 53 of the first patients to have been treated in the program, show that the majority demonstrated clinical improvement after taking remdesivir, but there have been limitations of these compassionate use data from a purely investigational perspective. Two Phase 3 studies are being run by Gilead in areas with a high prevalence of COVID-19 in the United States, Asia and Europe. But at present, it’s difficult for remdesivir to enroll patients into clinical study because there are many new investigational studies appearing and this research take up many resources, which has stalled enrollment in China of patients with severe symptoms.

The 11th Pharmacopoeia Commission Executive Committee Meeting – Review and Approval of Draft 2020 Chinese Pharmacopoeia

According to the “Pharmacopoeia Commission Constitution” and “People’s Republic of China Pharmacopoeia” (hereinafter referred to as “Chinese Pharmacopoeia”) preparation work procedures, on 9 April, 2020 the 11th Pharmacopoeia Commission Executive Committee meeting was held in Beijing. The meeting heard the report of the State Pharmacopoeia Commission on the preparation of the 2020 version of the Chinese Pharmacopoeia, reviewed and approved the draft version of the Chinese Pharmacopoeia in 2020. Chairman of the 11th Pharmacopoeia Commission, Director of the China National Medical Products Administration (NMPA) Jiao Hong, Deputy Chairman and Deputy Director of the National Health Commission Zeng Yixin attended and addressed the meeting. Chen Shifei, deputy chairman and deputy director of the State Food and Drug Administration, presided over the meeting. Lan Fen, Secretary General of the National Pharmacopoeia Commission, reported to all executive committees on the preparation of the 2020 edition of the Pharmacopoeia.

The 2020 version of “Chinese Pharmacopoeia” added 319 species, revised 3,177 species, no longer included 10 species, 4 species were combined and adjusted, and a total of 5,911 species were included. Chinese medicine contains 2,711 species, including 117 new ones and 452 revised ones. The second part contains 2,712 species of chemical drugs, including 117 new ones and 2,387 revised ones. The three parts of biological products contain 153 species, of which 20 are newly added and 126 are revised. Two newly added biological products are general rules and four are summarized. The four parts contain 361 general technical requirements, including 38 general rules for preparations (revised 35), 281 test methods and other general rules (newly added 35, revised 51), and 42 guidelines (newly added 12, revised 12). There are 335 species of medicinal excipients collected, of which 65 are newly added and 212 are revised.

First CLD-Related Thrombocytopenia Drug Avatrobopag in Approved in China

On 16 April, 2020, Shanghai Fusun Pharmaceutical Co., Ltd. announced that avatrobopag tables have been approved by the China National Medical Products Administration (NMPA), applying to the treatment of adult patients with chronic liver disease-related thrombocytopenia. In May 2018, avatrobopag was approved for marketing by the FDA and the Fusun Company obtained the permission of AkaRx Inc. for the exclusive sales agency rights of the new drug in the region (i.e., Mainland China and Hong Kong Special Administrative Region). In other words, AkaRx is still the owner of the new drug in the region, and sales of Fosun Pharma in the region will be provided by AkaRx. As China’s first approved oral thrombopoietin receptor antagonist (TPO-RA), avatrobopag will introduce a novel clinical treatment model for Chinese CLD-related thrombocytopenia patients.

Direct Settlement of Medical Insurance and Pharmaceutical Companies

On 21 April, 2020, the Hunan Medical Insurance Bureau issued a notice on the implementation of the ‘Hunan Provincial Pharmaceutical Procurement Platform Online Payment and Payment Implementation Rules’, requesting the first and second batch of national volume procurement of selected medicines and Hunan Province’s special antibacterial drug centralized purchase of winning bidders online payment and settlement of drug centralized purchases. This action solves the “triangular debt” problem of hospitals, medical insurance, and enterprises from the settlement link.

Structure-Based Design of Antiviral Drug Candidates Targets SARS-CoV-2 Main Protease

A team of Chinese scientists recently developed two novel compounds that inhibit the SARS-CoV-2 main protease (Mpro) and one of them is a drug candidate for further clinical studies. The research, published online in Science on 22 April 2020, was conducted by Professors LIU Hong and XU Yechun from the Shanghai Institute of Materia Medica (SIMM) of the Chinese Academy of Sciences (CAS), Professor YANG Haitao from the Shanghai Institute for Advanced Immunochemical Studies of Shanghai Technical University, Prof. ZHANG Lei-Ke from the Wuhan Institute of Virology of CAS, and their collaborators.

SARS-CoV-2 – the etiological agent responsible for the global COVID-19 outbreak – is an enveloped, positive-sense, single-stranded RNA virus and SARS-CoV-2 Mpro plays a vital role in its life cycle. Since SARS-CoV-2 Mpro has no human homologue, it is an ideal antiviral drug target. After analyzing the substrate-binding pockets of SARS-CoV-2 Mpro, the scientists designed and synthesized two compounds, 11a and 11b. A fluorescence resonance energy transfer (FRET)-based cleavage assay was then used to determine their IC50 values. The researchers also employed immunofluorescence, quantitative real-time PCR and plaque assay to monitor the antiviral activity of 11a and 11b. The results all showed these compounds exhibited good anti-SARS-CoV-2-infection activity in cell cultures. In addition, these compounds showed good Pharmacokinetics properties in vivo, suggesting they are promising drug candidates.

NMPA Held Video Meeting on Quality and Safety of New Coronavirus Detection Reagents and Ventilators

The China National Medical Products Administration (NMPA) convened a video meeting on the quality and safety supervision of new corona virus detection reagents and ventilators. The meeting pointed out that the current situation of prevention and control of the new coronavirus epidemic in China is gradually improving, but the international epidemic situation is accelerating its spread. The global demand for medical devices for epidemic prevention and control has increased sharply to ensure the quality of medical devices for epidemic prevention and control.

The NMPA will require medical device manufacturers enhance quality awareness, risk awareness and rule of law awareness, strictly implement regulations and standards, ensure that raw materials, production, and shipments are properly controlled, ensure continuous compliance with quality management systems, and do their best to prevent and control epidemic medical devices quality and safety management and production and supply work. Provincial drug regulatory departments should strengthen coordination with other departments closely, share information, and strengthen product quality and safety supervision.

Clinical Research
New Version of GCP Issued in China

On 26 April, 2020, the China National Medical Products Administration (NMPA) issued the new version of Good Clinical Practice that will be implemented formally on 1 July, 2020. Compared with the previous version, the new version includes most of the content of ICH E6 R2, making Chinese clinical research more compliant with international standards. In addition, there are differences from ICH E6 R2, for instance, in terms of the definition of CRO, in ICG E6 R2, CRO means A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor’s trial-related duties and functions, which just only delineates the responsibilities and tasks of performer, however, in new Chinese version of GCP, CRO includes responsibilities and tasks of two sides— performer or researcher. In conclusion, the new version makes progress from many aspects, to create a better clinic research atmosphere in China.

Medical Economy
The Epidemic has impacted the Market Value of Many Giants Pharmaceutical Companies

Recently, Global data released a new research report showing that 8% of the market value of the top 20 multinational pharmaceutical companies in the first quarter of 2020 has been lost because of coronavirus. Among the top 20 pharmaceutical companies by market capitalization, the share prices of seven companies rose. Gilead Sciences and Regeneron were particularly outstanding, with market values increasing by 14.5% and 32.5% respectively.

Clinical Trials
China’s CDE Drafts Guidance on Use of Imaging Endpoints in Cancer Trials

The China Center for Drug Evaluation (CDE) has published draft guidance on the use of imaging to assess the efficacy of anticancer drugs. CDE framed the guidance as a response to the need for new endpoints as the duration of survival for patients with some cancers increases. Imaging of tumors provides researchers with a way to quickly gauge if a drug is efficacious. However, the lack of relevant technical requirements or industry standards in China raises the risk that results will be affected by differences in how images are captured and analyzed. A desire to reduce that risk led CDE to publish the draft guidance. In the text, CDE discusses the standardization of imaging protocols, the qualification and training of operators, considerations for data locking and modification, and other matters that could affect the reliability of the findings of oncology clinical trials. CDE is accepting feedback on the draft guidance for one month.

RNF180/Septin9 Gene Methylation Detection Kit (PCR Fluorescence Probe Method) Approved

The China National Medical Products Administration (NMPA) approved the innovative product “RNF180 / Septin9 Gene Methylation Detection Kit (PCR Fluorescence Probe Method)” produced by Borcheng (Beijing) Technology Co., Ltd. This product is based on the principle of PCR fluorescent probe detection and is used for qualitative detection of RNF180 and Septin9 genes in human plasma in vitro. It is the first innovative tumor standard to detect the methylation of RNF180 and Septin9 genes by fluorescent quantitative PCR Gastric cancer diagnostic products. This product is suitable for patients who have been diagnosed and recommended by a clinician for gastroscopy and who refuse to undergo gastroscopy for personal reasons. This product is not used for cancer screening in the general population. Based on existing research, it is limited to those with a family history of gastric cancer or a high-risk group of people over 40 years of age. The final diagnosis of patients should be based on the results of gastroscopy.

Each year, ten graduating seniors from each of the USC Scholar Distinctions – Renaissance, Global, Discovery – are selected to receive a Discovery Scholar Prize ($10,000) towards graduate study or creative projects. The Discovery Scholar distinction honors undergraduate students who excel in the classroom while demonstrating an ability to create exceptional new scholarship or artistic works.For 2020, Reg. Sci. senior Pooja Singh has been awarded the distinction of being a USC Discovery Scholar and is a finalist for a Discovery Scholar Prize!

Pooja began her research in the Regulatory and Quality Science Department in Fall 2018 as an undergraduate researcher. She immediately began working on a project studying Naloxone and other opioid antagonist treatments for opioid reversal. From her initial findings, Pooja crafted a project to study why there has been a lack of novel antagonist treatments development. She more recently pivoted her project to look at clinical trials for Naloxone, examining the various populations that have been impacted by discriminatory trial inclusion and exclusion criteria.

Through her research, Pooja has shown time again the importance of self-motivation, hard work, and passion. She was awarded the Provost Undergraduate Research Fellowship in Fall 2018, Spring 2019, Summer 2019,  and Fall 2019. She has consistently demonstrated research well beyond the undergraduate level. She has presented her research at numerous conferences such as Association for Clinical and Translational Sciences and the American Pharmacists Association and has been published in peer reviewed publications multiple times.

Her ambition and compassion extend outside of research. She is the Pharmacy Chair of the USC Flying Samaritans, overseeing the pharmacy at the clinic site and coordinating clinic trips to Tijuana, Mexico to provide free healthcare for underprivileged community members. As the Co-President of the Green Ribbon Club at the university, she brings awareness to the importance of mental health among her peers.

Pooja will be joining the School of Pharmacy to begin working on her PharmD.  We all wish her the best of luck in winning the prize (to be announced in May)!

Highlight posted on April 17, 2020

Graduation is a time of bestowing diplomas and accolades. One of our students, Annie Ly, who is graduating from undergraduate and transitioning to graduate school in Regulatory Science, will be awarded an amazing distinction! Annie was recently named a USC Discovery Scholar. The USC Discovery Scholar distinction recognizes and celebrates graduating seniors who have excelled academically while making a meaningful contribution to their field of study through exceptional new scholarship or artistic work.

Annie has presented at professional and academic society meetings where she exquisitely combined her academic skills with her passion for research. Her skill and determination culminated in her award of the USC Provost Research Fellowship in Fall 2019. Annie is also the recipient of the USC Provost First-Generation Undergraduate Research Fellowship in 2018 and 2019. These fellowships have culminated in nine poster presentations: including poster presentations at American Pharmacists Association in 2020 and Translational Science in 2019. In addition, Annie was awarded 1st prize on a collaborative research presentation at the USC 21st Annual Undergraduate Research for Scholarly and Creative Work in 2019.

As a first-generation college student, Annie Ly has made the most of her undergraduate education. Amid her busy academic schedule, she finds time to give back to her community. Annie is president of RegSC, a student led organization dedicated to research in the field of Regulatory Science. She volunteers at Skid Row monthly, providing the residents with free blood glucose tests, blood pressure readings, water, and snacks. She previously served as Mentor for the Asian Pacific American Students Services (APASS) Peer program, mentoring first-year freshmen during the 2019-2020 school year. Currently, she provides mentorship to new undergraduate researchers and her freshmen residents in her role as a Resident Assistant. Annie serves as the Co-Director of the SplashSC student organization, which is an educational initiative that seeks to provide local high school students with the opportunity to learn what they want at no additional cost.


Congratulations to Annie, a leader both inside and outside of the classroom!

Highlight posted on April 16, 2020

On April 9th, Mr. DK Kim through his foundation “DK Kim Foundation” donated 10,000 surgical masks and 10,000 vinyl gloves to Keck Medical Center of USC.

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on April 7th, 2020

Indian Pharmaceutical Companies Accelerate their Entry into Chinese Market

In recent years, Indian pharmaceutical companies have accelerated their entry rate into the Chinese market. On 2 March, 2020, Treasure Island Pharmaceutical in China announced that they will team with Biological E. LTD in India, becoming the exclusive distributor of Daptomycin injection (500mg) for marketing, sales, and distribution in China. This cooperation demonstrates the positivity of Indian pharmaceutical companies playing more important roles in different drugs, and different dimensions in Chinese medical market, not just participating in the Active Pharmaceutical Ingredient market.

NMPA Publicly Solicits Opinions on Guidelines for Contract Production of Drugs

On 2 March 2020, the China National Medical Products Administration (NMPA) issued a draft guideline for quality agreement on contract production of drugs and a reference template which are now open to the public for comments. The guideline is formulated to guide and supervise drug marketing authorization holders and pharmaceutical manufacturers to fulfill quality assurance obligations for drugs by assigning contract production quality agreement(s). The quality agreement should specify Good Manufacturing Practice responsibilities of the holder and the trustee, and stipulate that the holder is responsible for quality, safety, and effectiveness of drugs during the entire production process.

Breaking the Space Constraints of Doctor-Patient Communication, China Launches Online Diagnosis and Treatment Service for Chronic Diseases

On 2 March, 2020, the China National Healthcare Security Administration and National Health Commission issued a joint release, declaring that on-line medical services for common and chronic diseases provided to the insured can be included in the payment scope of the medical insurance fund. In other words, these patients can see a doctor, obtain electronic prescriptions on-line, and buy drugs at designated pharmacy sites. The change will rebuild sales of drugs for chronic diseases, at a time when maintaining high activity and retention of patients is the main challenge for pharmaceutical companies.

Bioabsorbable Coronary Rapamycin Eluting Stent System Approved

The China National Medical Products Administration (NMPA) approved the innovative product “bioabsorbable coronary rapamycin eluting stent system” produced by Shandong Huaan Biotechnology Co., Ltd. The product consists of a stent and drug delivery system. The stent is composed of a stent base, a development marker, and a drug carrier coating. It is used to treat intravascular stenosis in patients with primary coronary atherosclerosis, improve coronary blood flow and prevent restenosis. The reference blood vessel diameter is 2.75mm to 3.75mm, and the lesion length is ≤24mm. Compared with traditional metal drug stents, this product is expected to have the following advantages:

  1. The final degradation products of the stent are water and carbon dioxide, which reduces the trouble of advanced thrombosis.
  2. The stent is completely degraded and absorbed, reducing a long-term foreign body inflammation reaction.
  3. Compatible with MRI-CT, etc.
  4. Stent intervention is convenient again after the target lesion is restenosis.
  5. The normal physiological function of the target lesion vessel will be partially restored and improved. 

NMPA Continues to Approve New Coronavirus Rapid Detection Products

The China National Medical Products Administration (NMPA) passed an emergency review and approval of a new Coronavirus (2019-nCoV) antibody detection kit (chemiluminescence microparticle immunoassay) from Xiamen Wantai Kerry Biotechnology Co., Ltd. The product adopts immunoassay technology combining nano-paramagnetic particles with chemiluminescence. Using the double-antigen sandwich principle and supporting a full-automatic chemiluminescence instrument, it can qualitatively detect the new coronavirus (2019-nCoV) antibody in human serum or plasma by detecting the chemiluminescence reaction signal. The product approval expands the supply of rapid detection reagents and further serves the needs of epidemic prevention and control.

Medical Services
Leveraging the New Format of ‘Internet + Medical Health’ to Fulfil the Drug Needs of Patients with Non-new Coronavirus Pneumonia 

Recently, the China National Healthcare Security Administration issued guidance on promoting ‘Internet + Medical Health’ for medical insurance services during the new coronavirus pneumonia outbreak, which points out that ‘Internet +’ return visit service for common and chronic diseases has been included in the payment scope of medical insurance fund. The agency encourages designated medical institutions to provide ‘not-face-to-face’ drug purchase services and innovate delivery methods, to avoid crowd gathering and reduce the risk of cross-infection. Many pharmaceutical companies have been paying close attention to the demands of patients, while actively responding to government calls. For example, in the field of diabetes, Eli Lilly has launched a new patient service on their patient welfare platform. Patients can scan a QR code to find a professional doctor for consultation directly on the internet hospital platforms, and the doctor will issue a condition-specific prescription. Patients can place an order online immediately with a prescription, and get fast delivery from offline pharmacies. This move helps diabetic patients take medicine at home with peace of mind and guarantees their uninterrupted treatment during the epidemic.

Drug Traceability System for the Whole Cycle and Whole Process has been Improved

On 11 March 2020, the China National Medical Products Administration (NMPA) announced that specific standards have been proposed for drug data traceability specifications, such as drug marketing authorization holders and manufacturers, drug distributors, drug users, consumer inquiry center and basic data exchange technology.

The release of the drug traceability specification has further consolidated the foundation for the implementation of the Drug Marketing Authorization Holder (MAH) system, and imposed stricter drug quality responsibilities on upstream and downstream industries.

The NMPA Emergency Approval of Coronavirus Detection Products

The China National Medical Products Administration (NMPA) has approved two new coronavirus (2019-nCoV) IgM / IgG antibody detection kits (colloidal gold method) from Nanjing Nuoweizan Medical Technology Co., Ltd. and Zhuhai Lizhu Reagent Co., Ltd. These antibody detection reagents use immunochromatographic technology to indirectly and legally detect human new coronavirus (2019-nCoV) IgM and IgG antibodies. These products were approved which further expanded the supply of rapid detection reagents and served the needs of epidemic prevention and control.

Halving Medical Insurance Premiums

Recently, the China National Healthcare Security Administration made it explicit that to ensure the medium and long-term balance of medical fund revenues and expenditures, the employees’ medical insurance premiums can be halved and levied for a maximum of five months, which is expected to reduce the burden on enterprises by about 150 billion yuan. For Beijing City as an example, on 5 March 2020, in accordance with national requirements, the Beijing Medical Insurance Bureau issued a joint document with the finance and taxation departments, clarifying that starting in February 2020, City employees basic medical insurance units will be charged a 50% reduction for a period of five months thereby reducing the unit burden by more than 26 billion yuan.

Medical Devices
China’s NMPA Outlines Plans to Randomly Inspect Medical Device Operations

The China National Medical Products Administration (NMPA) plans to conduct random inspections as part of its efforts to ensure the quality of medical devices sold in China. The document calls for national and regional regulators to formulate an annual inspection plan in the first quarter of each year. The NMPA wants the national and regional plans to complement, not duplicate, each other. This objective will be supported by differences in the priorities that NMPA established to shape the creation of the inspection plans. Other sections of the document describe topics including the experience regulatory officials involved in the work should have and the consequences of noncompliance. Manufacturers may need to pull devices from the market, perform in-depth self-assessment and adopt risk-control measures. The NMPA expects companies to keep risk-control measures in place while applying for re-inspection. The document places responsibilities and restrictions on regulatory officials involved in the work, specifically prohibiting staff from releasing inspection information without authorization.

Medical Devices
China’s First Medical Device Product is Approved for Marketing Using Real-World Data

On 26 March 2020, the National Medical Products Administration (NMPA) approved the registration of “Glaucoma Drainage Tube” produced by Allergan, Inc. The mechanism action of this medical device is through diverting fluid from the eyeball to treat glaucoma. Using real world data to replace the complex clinical trials in R&D procedure is a vital measure to reduce the cost of R&D of medical products, which also could speed the process of marketing. In September 2019, the Chinese government conducted real-world data application research in the Boao Lecheng Pioneer District, turning into real-world evidence the clinical data of drugs and medical devices that are not registered in China but urgently needed for clinical import. The “Glaucoma Drainage Tube” produced by Allergan is the first medical product approved for marketing using real world data.

NMPA Approved the New Chinese Medicine Mulberry Branch Total Alkaloid Tablets

The China National Medical Products Administration (NMPA) approved the application of Mulberry Total Alkaloid Tablets. The main component of this medicine is the total alkaloids extracted from mulberry branches, which are used for type 2 diabetes in combination with diet control and exercise. Beijing Wuhe Boao Pharmaceutical Co., Ltd. is the holder of marketing authorization for this product. The product is subject to technical review in accordance with the priority review process. The clinical trial results show that there is a statistical difference compared with the placebo control group, which can effectively reduce the level of glycated hemoglobin (HbA1c) in patients with type 2 diabetes.

NMPA Emergency Approval of Rapid Detection of New Coronavirus Nucleic Acid

The China National Medical Products Administration (NMPA) approved a new Coronavirus rapid detection product, the new Coronavirus 2019-nCoV nucleic acid detection reagent developed by Shanghai Rendu Biotechnology Co., Ltd., using RNA-specific target capture and transcription-mediated real-time thermostatic amplification. The nucleic acid extraction and amplification steps can be completed automatically in a reaction tube and results can be obtained in 90 minutes, and continuous and parallel detection can be realized to improve detection efficiency. Relevant data show that the sensitivity and specificity of detection results can reach the level of traditional Polymerase Chain Reaction methods. Previously, the NMPA approved the Hangzhou Newstar Biotechnology Co., Ltd. New Coronavirus 2019-nCoV nucleic acid detection kit (constant temperature amplification-real-time fluorescence method) and Anbang (Xiamen) Biotechnology Co., Ltd. 2019-nCoV nucleic acid detection kit (hybrid capture immunofluorescence method) 2 nucleic acid rapid detection reagent products. These three nucleic acid rapid detection reagents shorten the detection time of nucleic acid detection reagents, improve the detection efficiency, and improve epidemic prevention and control. The NMPA also approved Shanghai Fosun Long March Medical Science Co., Ltd.’s new coronavirus (2019-nCoV) nucleic acid detection kit (fluorescence PCR method) product, which further expanded the supply of detection reagents for epidemic prevention and control.

National Medical Products Administration issued two heavy documents in succession affecting the entire life cycle of drugs

On 31 March, 2020, the China National Medical Products Administration (NMPA) issued two documents to deploy and implement “The Measures for Administration of Drug Registration ” and “The measures of Supervision and Administration of Drug Production”, which bring significant impact on drug management. According to industry experts, the main objectives of these two documents are to accelerate new drugs to market by setting up four expedited pathways (breakthrough therapeutic drugs, conditional approval, priority review and approval, and special approval) and fully implement the drug Marketing Authorization Holder system, achieving traceability of drug quality.

Approval of Almonertinib for treatment of non-small cell lung cancer

The China National Medical Products Administration (NMPA) issued a statement on 31 March, 2020 that it conditionally approved the Class 1 innovative drug Almonertinib (HS-10296) through the priority review process. Jiangsu Hansoh Pharmaceutical Group Co., Ltd is the market authorization holder of the drug. Almonertinib is a kinase inhibitor of epidermal growth factor receptor and it is an innovative drug independently researched and developed in China with independent intellectual property rights. The listing of this product helps to improve the disease progression of patients with T790M-positive non-small cell lung cancer after the first generation of EGFR-TKI treatment, and provides new drug options for patients with non-small cell lung cancer. The NMPA requires the market authorization holder to continue to complete ongoing clinical studies as planned after the product is marketed.

Medical Devices
China NMPA Shares the Medical Device Unique Device Identification Database

Starting 31 March, 2020, the China Unique Device Identification (UDI) Database will be opened, which can be used by the public, medical device manufacturers, medical device operators and medical institutions in three ways: query, download and interface docking. The details of data query are displayed according to different characteristics of product identification. At the same time, auxiliary functions such as folding or expanding, downloading, printing, and historical version records of query data are set to meet the diverse needs of users. In addition, the database sets data download function and data sharing mode of interface docking. Next the China National Medical Products Administration (NMPA) will gradually advance the construction of the database, improve related functions, and continue to provide support and services for UDI data sharing.

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates March 2020. For general information on Education Initiatives, click hereHighlight posted on March 28th, 2020


Texas Compounder Found Guilty of Multimillion Dollar Healthcare Fraud

A federal jury in Houston, Texas found a drug compounder guilty of billing the federal government more than $20 million for unnecessary compounds. The fraudulent scheme involved the creation of compounded pain cream prescriptions and billing healthcare programs for injured state and federal employees. In total, the racket billed the government approximately $21.8 million for compounded gels and creams.

Coronavirus Disease 2019 (COVID-19)
FDA Unveils Guidance for Trials Impacted by COVID-19

The U.S. Food and Drug Administration (FDA) issued new final guidance to help sponsors assure the safety of trial participants, maintain compliance with good clinical practice (GCP) and minimize risks to trial integrity during the COVID-19 pandemic. The FDA urges sponsors and clinical investigators to engage with Institutional Review Boards (IRBs) / Independent Ethics Committees (IECs) “as early as possible when urgent or emergent changes to the protocol or informed consent are anticipated as a result of COVID-19.”David Borasky, Vice President of IRB Compliance at WCG, said in a webinar on trials impacted by COVID-19 that IRBs want to know about changes as soon as possible and hope that they will be reported within five days, but they understand the circumstances.

FDA Looks to Speed Access to Potential COVID-19 Treatments

President Donald Trump said in a press conference alongside U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn that, ” With the potential for a coronavirus vaccine likely more than a year away, FDA is doing what it can to speed access to potential COVID-19 treatments. Trump also discussed Chloroquine and Gilead’s experimental antiviral Remdesivir as potential candidates to treat COVID-19. Bayer, a manufacturer of chloroquine, said that it is looking to obtain an Emergency Use Authorization for the drug in the U.S. as a COVID-19 treatment.

FDA Revamps Adverse Event Reporting Guidance for COVID-19

The U.S. Food and Drug Administration (FDA) on Thursday March 19, 2020, revised its guidance on post market adverse event reporting for medical products and dietary supplements during a pandemic to apply the guidance to the ongoing coronavirus disease (COVID-19) pandemic. The previous version of the guidance from 2012 specifically applied to influenza pandemics. FDA clarified in the revised guidance that it applies to all pandemics, including COVID-19. There are situations where the FDA will expect companies to comply with normal reporting requirements during a pandemic, such as newly emerging product-related safety issues and product problems associated with adverse events. The guidance also features a table detailing whether companies experiencing pandemic-related employee absenteeism should store or submit reports for various products based on the product type and use.

FDA to Implement all COVID-19-Related Guidance Immediately, Without Public Comment

Although COVID-19-related guidance documents will be immediately implemented without prior public comment, the U.S. Food and Drug Administration (FDA) said it will still solicit comment, review all comments received, and revise guidance documents as appropriate. In addition, the FDA said it intends to publish periodically a consolidated Notice of Availability (NOA). The Federal Register notice said “This periodic NOA will announce the availability of all the COVID-19-related guidance documents that issued during the relevant period. The consolidated NOA will provide instructions to the public on submitting comments on COVID-19-related guidance documents.”

Convalescent Plasma: FDA Facilitating Emergency Access

One potential treatment for COVID-19, known as convalescent plasma, may be derived from patients who have already recovered from the disease and they might contain antibodies to the virus that could be effective against the infection. The U.S. Food and Drug Administration (FDA) said it will allow patients with serious or immediately life-threatening COVID-19 infections to use single patient emergency Investigational New Drug Applications (eINDs) to obtain access to the investigational plasma.

FDA, MHRA Seek to Boost Ventilator Supply

As hospitals face an influx of patients needing mechanical ventilation due to coronavirus disease (COVID-19), regulators including the U.S. Food and Drug Administration (FDA) and the U.K Medicines and Healthcare products Regulatory Agency (MHRA) are loosening requirements for ventilators to boost supply of the devices. The FDA issued an immediately effective guidance, allowing device makers to make modifications to already cleared products without submitting a premarket notification (510(k)) during the public health emergency. MHRA provided a set of specifications to meet “minimally acceptable” performance criteria for the devices during the outbreak.


Dietary Supplements
FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity

The U.S. Food and Drug Administration (FDA) said they see Cannabidiol (CBD) being marketed in a number of different products, such as oil drops, capsules, syrups, food products, chocolate bars and teas, cosmetics, and other topic lotions creams, as well as products marketed for pets. The FDA plans to continue monitoring the marketplace for unlawful CBD products and would like to work closely with stakeholders and industry to develop high-quality data to close the knowledge gaps on CBD.

March 10, 2020 – FDA Warns Retailers, Manufacturers to Remove Unauthorized E-Cigarette Products from Market

The U.S. Food and Drug Administration (FDA) issued 22 warning letters to e-cigarette product retailers and manufacturers who sell flavored, cartridge-based electronic nicotine delivery systems (ENDS). The FDA will prioritize enforcement against the following ENDS products: 1) flavored, cartridge-based ENDS; 2) all other ENDS products for which the manufacturer has failed to take adequate measures to prevent underage access; and 3) any ENDS product that is targeted to youth or likely to promote use by youth.

User Fee Reauthorizations Begin With Public Meeting on MDUFA V

Prior to beginning further negotiations with industry on the medical device user fee authorization (MDUFA V), goal dates and prices, the U.S. Food and Drug Administration (FDA) is required by law to request public input on the reauthorization, hold a public meeting where different views can be presented, including suggestions for changes to goals, provide 30 days for written comments after the meeting and publish those comments on the FDA website.

OIG Says FDA Needs More Supply Chain Authority

The Office of Inspector General (OIG) looked at 44 drug products, tracing them backwards through the supply chain from dispenser to manufacturer, and found that ownership of seven could not be completely traced using the information currently required by the Drug Supply Chain Security Act (DSCSA). For 21 of the drugs, the OIG could not identify the shipping location of trading partners or their third-party logistics providers. That information is not currently required by DSCSA and the inspector general’s office said this could cause problems during a drug safety emergency.

House Committee Wants FDA Briefing on Marketing Status Reporting Requirements

This question of marketing status reporting requirements came after 44 states filed a complaint against 20 generic drug makers last May alleging they engaged in price fixing and market manipulation, in some cases temporarily delisting products in order to re-enter at a higher price at a later date. Novartis and Sun Pharma, parent companies of Sandoz and Taro denied the claims. Sandoz later admitted to the criminal conspiracy charges and agreed to pay a $195 million fine. In February Taro’s Vice President of Sales and Marketing was indicted for conspiring to fix generic drug prices.

Coronavirus Disease 2019 (COVID-19)
Coronavirus: FDA, FTC Warn Seven Firms Over Deceptive Claims

The sale and promotion of fraudulent COVID-19 products is a threat to public health and the U.S. Food and Drug Administration (FDA) claims to have an aggressive surveillance program to monitor online sources for health fraud products.

Coronavirus Prompts FDA to Cancel Travel, Postpone Inspections and Meetings

The U.S. Food and Drug Administration (FDA) will postpone most foreign inspections and inspections will be done on a case-by-case basis. Also, the FDA canceled all foreign travel by agency officials and is limiting domestic travel to critical missions.

EMA: No Coronavirus-Related Shortages Yet, Shortage Steering Group Formed

The European Medicine Agency (EMA) reported no drug shortages or supply disruptions for products marketed within the E.U. as a result of the novel coronavirus outbreak. The outbreak has sparked fears of drug shortages due to supply chain disruptions in China and abroad; much of the world’s active pharmaceutical ingredients are made in China.


Spike in FDA Warning Letters to Slow Indian Generics in U.S.

The U.S. Food and Drug Administration (FDA) issued more than double the number of warning letters to Indian facilities in the first ten months of 2019 compared to the previous year. It is estimated that the FDA enforcement actions will delay approximately 180 abbreviated new drug applications, or around 18 percent of total U.S. applications by India’s large drugmakers.

FDA Advises Sponsors of New Drugs, Biologics on Accessing Immunotoxicity

The U.S. Food and Drug Administration (FDA) detailed in draft guidance how sponsors of nonclinical safety evaluations of new drugs and therapeutic proteins should consider their impact on the immune system. Safety evaluations should include both the intended and unintended actions on the immune system. The FDA also noted that effects can include “a reduction or an increase in activity, as well as changes in the immune balance.”

Foreign Governments ‘Free-Riding’ on U.S. Drug Research, White House Says

The White House Council of Economic Advisers (CEA) noted that foreign governments have implemented price controls and “nonmarket-based pricing practices” that keep drug prices below their true value. For example, it found that European prices for top-selling drugs were 32 percent of what U.S. consumers were paying in 2017, down from 51 percent in 2003. Most developed countries do not adequately contribute to funding medical innovation, leaving the U.S. to bear a “highly disproportionate part of that burden” as Americans pay higher prices for drugs and help provide “the incentives needed to entice investors to develop new therapies,” CEA said.

Clinical Trails
FDA Guidance Snapshots: Launch of a New Pilot

The U.S. Food and Drug Administration (FDA) unveiled a new pilot program to release “Guidance Snapshots” for a subset of cross-cutting guidance documents on topics related to modernizing drug clinical trials and accelerating drug development. Two of the snapshots are related to guidance providing recommendations to drugmakers on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing. The third snapshot is on developing targeted therapies in low-frequency molecular subsets of a disease.

Medical Devices
Device Industry, Notified Bodies to Offer Feedback to MDCG at MDR Meetings

The European Commission’s Medical Device Coordination Group (MDCG) held a series of meetings, partly to hear additional feedback from industry and notified bodies on their preparedness for the application of the Medical Devices Regulation (MDR) on 26 May, 2020. Expert panels, the Eudamed database and developments with regard to guidance on the Medical Device Single Audit Program will be discussed. The MDCG also expects to discuss the endorsement of guidance related to device software, and hear information on guidance on clinical evidence requirements needed for devices previously certified under Directives 93/42/EEC and 90/385/EEC, known as legacy devices.

Coronavirus Disease 2019 (COVID-19)
Coronavirus (COVID-19) Update: FDA Issues New Policy to Help Expedite Availability of Diagnostics

The new policy is for certain laboratories that develop and begin to use validated COVID-19 diagnostics before the U.S. Food and Drug Administration (FDA) has completed review of their Emergency Use Authorization (EUA) requests. The FDA guidance provides recommendations for test developers, including information regarding test validation, FDA notification and interim confirmatory clinical testing. Following the completion of their test validation, laboratories should communicate with the FDA, via email, in order to notify the agency that the test has been validated. Laboratories should submit a completed EUA request within 15 business days of notification.

USC Int'l Ctr for RegSci/SC CTSI logos

Quality by Design in Clinical Trials
Friday, March 13, 2020
9am – 3pm

To meet the university’s public health requirements, the Department of Regulatory and Quality Science has moved this onsite event to a DIGITAL PLATFORM.  There will be no in-person attendance.
The Zoom platform allows for live-streaming of presentations, audience interaction, and polling.

Download Digital Binder 

RegSC, USCs only undergraduate club for research in the field of regulatory science, was excited to participate in a faculty-moderated USC Diversity, Equity and Inclusion Week round table on March 6, 2020. Students and staff not only talked-the-talk, they were decked out in different hues from the rainbow to emphasize that inclusion is very much part the dialogue at Regulatory Sciences because of direct linkages to health outcomes. Whether it is historically underrepresented populations (pediatrics, geriatrics, women) in clinical trials that receive an improper medicine dosage, a clinical trial participant who is presented information in language which is clear, understandable, and non-technical, or existing disparities within the prescribing patterns of medical providers of opioids due in part to prejudice and erroneous stereotyping.

Together we can make a difference and expand clinical trial diversity for the improvement of all of our health.  Let us FIGHT ON for a more representative body within clinical trial research.

To view full presentation by Dr. Pacifici and Dr. Church click here.

For general information on Research Activities, click here.
Highlight posted on March 7th, 2020


Improving effective monitoring of investigator-initiated trials (IITs) at academic medical centers is one of the challenges undertaken by the Southern California Clinical and Translational Sciences Institute (SC CTSI). In a February 18, 2020 webinar hosted by the Trial Innovation Network, the SC CTSI team of Dr. Pacifici and Dr. Pire-Smerkanich from the Regulatory Science Department and Dr. April Armstrong and Dr. Nicki Karimipour from SC CTSI presented on the on-going development of IITs focused self-study monitoring tools developed over the last half year. The presenters shared the experience gained from a recently completed four-study real-world pilot intended to train a nucleus of senior coordinators in clinical trial monitoring using the self-study monitoring tools. The pilot study results support the SC CTSI self-study monitoring tools as a platform for academic centers around the country to internally create pools of effective monitors for IITs and ultimately contribute to the improvement of IIT-based data quality and patient safety.

Visit the Webinar here.  For a related TrialSite News article please click here.

For general information on Education Initiatives, click hereHighlight posted on March 4th, 2020

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on March 2nd, 2020

Epidemic Prevention
NMPA Epidemic Prevention and Control Work

The China National Medical Products Administration (NMPA) engaged the China Food and Drug Inspection and Research Institute, Medical Device Technology Evaluation Center, and Drug Evaluation Center and other units to investigate and supervise the prevention and control work of new coronavirus infection. The NMPA emphasized that epidemic prevention and control work is the most important task at present and will fully supports scientific research on medical equipment for coronavirus prevention and control, including emergency approvals. To date, seven coronavirus nucleic acid detection reagents have been approved to meet the needs of epidemic prevention and control.

Gilead’s New Drug Remdesivir Will Be Launched in a Phase III Clinical Trial for the Treatment of COVID-19

Gilead’s new drug Remdesivir played an important role in treatment process for the first confirmed case of COVID-19 in the United States. Thus, the Chinese government decided to launch a phase III clinical trial of Remdesivir to verify its safety and effectiveness. It is reported that the Phase III clinical trial of the drug will have Capital Medical University as the sponsor with Professor Cao Bin, director of the Department of Respiratory and Critical Care Medicine, China-Japan Hospital, as lead investigator. Plans are to enroll 270 patients.

China’s CDE Limits Face-to-Face Interactions to Curb Spread of Coronavirus

China’s Center for Drug Evaluation (CDE) has taken steps to limit face-to-face interactions between staff and people at companies it regulates. CDE initiated the changes in response to the control measures implemented by the Chinese government to curb the spread of the coronavirus outbreak. In a bid to stop the virus spreading out from the city of Wuhan, Chinese government officials have put in place measures that restrict the movement of people. CDE responded to those measures on Monday with a set of changes specific to its operation. The changes eliminate several forums for face-to-face interaction and replace them with remote communication. As of 3 February, 2020, CDE will make greater use of its capacity to receive information electronically. CDE has also suspended in-person delivery of documents, and will only receive materials by mail. The changes were implemented alongside a new approach to consultations between regulators and the companies they oversee. CDE has suspended on-site, in-person consultations and extended hours during which it will conduct meetings via telephone to compensate for the restrictions. Applicants can also send CDE questions online and receive a response within 15 working days. As such, CDE has said developers of coronavirus products can contact the center at any time.

Epidemic Prevention
NMPA Has Enlarged Party Group Meeting

On 3 February, 2020, the China National Medical Products Administration (NMPA) held a party group enlarged meeting to convey the spirit of Xi Jinping’s speech at the Standing Committee of the Political Bureau of the Central Committee. Meeting requirements include: Crack down on illegal manufactures and sales of fake and inferior drugs and medical devices. Strengthen supervision of the quality of medicines and equipment which is for coronavirus prevention and control, the same as emergency approval. Support effective drugs and vaccines development, and strengthen the supervision of clinical trials for emergency approval. Ensure the supply of materials for epidemic prevention and control. Publish accurate and authoritative information timely. Coordinate annual tasks. Do a good job of protecting workers, especially first-line workers, and strictly prevent the spread of the new coronavirus.

Epidemic Prevention
10 Ministries Jointly Crack Down on Illegal Sale of Wildlife Products, Masks and Other Protective Products

On 2 February, 2020, the Market Administration and ten other ministries held a special law enforcement action deployment meeting to combat illegal transactions in wildlife and protective products such as masks. The meeting stressed that any form of wildlife trading activities is strictly prohibited during the coronavirus epidemic. Enforcement measures include: Crack down on illegal production and sale of masks and other protective products. Investigate and punish the selling medical devices without authorization. Investigate and punish the selling ordinary and industrial dust masks as medical masks, and repackaging and selling expired masks. Investigate and deal with products that do not meet the requirements of safety protection standards. Crack down on price increases. Crack down on recycling and operating medical waste in violation of legal provisions. The meeting also requested that publicly verified cases of law be promptly disclosed to the public.

Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 Gene Mutation Detection Kit Approved

China National Medical Products Administration (NMPA) approved the innovative product “Human EGFR / KRAS / BRAF / HER2 / ALK / ROS1 Gene Mutation Detection Kit (Semiconductor Sequencing Method)” produced by Xiamen Feishuo Biotechnology Co., Ltd. This product is used for qualitative detection of EGFR / KRAS / BRAF / HER2 / ALK / ROS1 gene mutations in formalin-fixed paraffin-embedded (FFPE) tissue samples from patients with non-small cell lung cancer (NSCLC). This product is based on a common polymerase chain reaction (PCR) platform that combines specifically modified primers and RingCap loop-mediated amplification technology to detect mutant genes contained in DNA / RNA samples. Using specific modified primers for PCR amplification of the target sequence, meanwhile, using RingCap loop-mediated amplification technology to modify the end of the amplified product, linking the specific sequence ends, combined with a special PCR reaction program and the use of RingCap enzyme, Library construction of target sequences in sample DNA / RNA for high-throughput sequencing is achieved on common PCR platforms to achieve accurate detection of multi-gene and multi-target mutations. The NMPA will strengthen supervision of after-marketed clinical trials.

IND of Shanghai Junshi Biosciences’ FIH anti-BTLA Antibody for Cancer Treatment Approved

Shanghai Junshi Biosciences announce that the company has received the Clinical Trial Approval for the ‘recombinant humanized anti-BTLA monoclonal antibody injection’ (project code: TAB004/JS004) from the China National Medical Products Administration (NMPA). JS004 is the world’s first anti-BTLA monoclonal antibody for cancer treatment approved for clinical trial. It is also the second drug candidate independently developed by Junshi Biosciences that obtained IND approval both from the NMPA and the U.S. Food and Drug Administration (FDA) after toripalimab. Currently, there are no products with similar targets on the market. Pre-clinical studies have shown that JS004 can promote tumor-specific T cells proliferation, enhance lymphocyte function, reduce tumor burden and increase survival rates in a BTLA humanized mouse tumor model. When combined with toripalimab, TAB004 could further enhance the proliferation of tumor-specific T cells and the production of anti-tumor cytokines, offering more options for combination therapy.

Medical Services
China National Health Commission Emphasizes the Need to Strengthen Internet Diagnosis and Treatment Consulting Services

On 7 February, 2020, the General Office of National Health Commission issued a notice on doing a good job of internet diagnosis and treatment consulting services in epidemic prevention and control, and proposed to make full use of ‘Internet + Medical Health’, to provide high-quality and convenient consulting services for the masses. The notice emphasized the need to vigorously carry out internet diagnosis and treatment services, especially for fever patients, and improve the ‘Internet + Medical Health’ service function, including online health assessment, medical guidance, chronic disease return visits, and psychological counseling. At the same time, provincial health administration departments should establish a unified internet medical service platform and a new coronavirus pneumonia prevention and control service management platform, centrally integrating and releasing the registered internet hospitals and diagnosis and treatment platforms, so as to facilitate the masses to obtain relevant diagnosis and treatment service information in a timely manner.

The Coronavirus in China Could Threaten Pharma’s Ingredient Sourcing

Recently, the increasing number of cases and various measures to prevent the coronavirus epidemic have caused a shortage of medical supplies in China. Most protective products (such as masks) have been used up. As the virus continues to spread, a new question arises: because China will give priority to its own medical resources and APIs, will this affect the supply of medicines in other counties/regions? The coronavirus scare has added a new dimension with an air of uncertainty around how the supply situation from China will unfold. Indian drug manufacturers are to a large extent dependent on China for sourcing drug ingredients or active pharmaceutical ingredients. Currently, the Chinese government has extended the New Year holidays from 25 January, 2020 until mid-February. However, if the holiday gets extended further then, Indian drug manufacturers, mostly formulation plants, which use the drug ingredients to make the tablets and capsules, could get impacted.

China’s First PD-L1 Drug is Going On Sale, New Choice for Patients with Stage III Non-small Cell Lung Cancer(NSCLC)

AstraZeneca’s PD-L1 mAb, Durvalumab injection, has been approved by the China National Medical Products Administration (NMPA) on 6 December 2019. The indication is for the treatment of patients with unresectable, stage III NSCLC who have not progressed after receiving concurrent platinum-based chemotherapy and radiotherapy.

The Department of Medicare Published Medical Insurance Guidelines during Epidemic Prevention

The Chinese government requires that the medical insurance department shall take timely measures to protect the interests of insured persons in the prevention and control of the coronavirus epidemic. First, the medical insurance department should ensure basic benefits according to Articles 28 to 32 of the ‘Social Insurance Law’. In addition, it is necessary to take relevant emergency measures in a timely manner in accordance with the needs of epidemic prevention and control, and in accordance with the severity of the situation, by the unified decision-making of the competent national authority or the temporary authorization of the provincial legal authority, for instance, it’s feasible to cancel reimbursement differences between two places.

As of February 9, 2020, a Total of 607 Specifications Have Passed Consistency Evaluations in China, Involving 221 Varieties

Generic drug consistency evaluation refers to the quality consistency evaluation of generic drugs that have been approved for marketing according to the principle of consistent quality and efficacy of the original drug. On 26 May, 2016, China officially launched the consistency evaluations, according to the latest statistics. As of 9 February, 2020, a total of 607 specifications have passed consistency evaluations in China, involving 221 varieties.


Coronavirus Prevention and Control Work Strengthened

The Standing Committee of the Political Bureau of the Central Committee of the Communist Party of China met on 12 February 2020 in response to the coronavirus epidemic. The meeting emphasized the need to strengthen the supply guarantee for medical supplies to support manufacturers of masks and medical protective clothing and to prioritize key areas for these urgently needed supplies. At the same time, the government is focused on assuring the production and supply of daily necessities. Because the epidemic coincides with spring ploughing, it is critical to pay close attention to organizing the supply of agricultural materials (seeds, fertilizers, feed) to implement spring planting to consolidate the foundation of agricultural production. For non-epidemic prevention areas, it is essential to implement precise prevention and control by districts and tiers to recover economic and social order.

Approval of Coloprevir Hydrochloride Capsules for Treatment of Chronic Hepatitis C

The China National Medical Products Administration (NMPA) approved priority review of the class 1 innovative drug coloprevir hydrochloride capsule (brand name: Kailiwei) by Beijing Kaiyingerling Biotechnology Co., Ltd. This product is used in combination with sofosbuvir for the treatment of chronic hepatitis C virus (HCV) infections in adults with type 1, 2, 3, and 6 who are newly treated or interferon-treated, with or without compensated cirrhosis. Coloprevir hydrochloride is an NS5A protein inhibitor that blocks replication and assembly of HCV. Coloprevir hydrochloride capsules will help increase the availability of domestic anti-HCV drugs and meet the needs of clinical medication.

Blood Products
Therapeutic Specific Immune Blood Product for COVID-19 Virus Put into Clinical Practice

The China National Biotec Group (CNBG) announced that it has completed collection of plasma from COVID-19 convalescent patients and carried out preparation of specific immune blood products and immunoglobulin. After rigorous blood biosafety testing, virus inactivation, and antiviral activity testing, a COVID-19 immune plasma product has been put into clinical practice for critical patients. It is reported that the product is composed of plasma containing high titer specific antibodies of COVID-19 virus and is prepared by virus inactivation, neutralization antibody against new coronavirus, and multiple pathogenic microorganism detection procedures. Clinically, after 12 to 24 hours of treatment, clinical symptoms of patients improve significantly with dramatic decrease of main inflammatory indicators, an increased proportion of lymphocytes, and improved key indicators such as blood oxygen saturation and viral load. At present, in the absence of vaccines and specific therapeutic drugs, this blood product is the most effective treatment for new coronavirus infections, which can significantly reduce the mortality of critical patients.

Approval of Favipiravir Tablets, the First Drug with Potential Efficacy for Pneumonia Caused by COVID-19

On 17 February 2020, Zhejiang Hisun Pharmaceutical Co., Ltd. announced that its Favipiravir was conditionally approved by the China National Medical Products Administration (NMPA) in response to the new coronavirus epidemic. The drug is used to treat new or re-emerging influenza in adults (only for use when antiviral treatment is ineffective). The Chinese Clinical Trials Registry (ChiCTR) posted that three clinical trials of Favipiravir for the treatment of coronavirus pneumonia have been conducted, and some clinical cases have shown preliminary obvious efficacy and lower adverse reactions. During the outbreak, NMPA has fast tracked approval of coronavirus related drugs. The entire approval process, from the company’s urgent submission of a listing application, to acceptance by NMPA, to final approval, took only 10 days. Favipiravir was approved conditionally, and pharmacy and clinical pharmacology follow-ups should be conducted. There will also have to be a new drug monitoring period and a system for reporting adverse reactions to ensure drug safety.

Drug Economy
Multinational Pharmaceutical Companies Released 2019 Financial Results

Fifteen multinational pharmaceutical companies released their 2019 financial results. Pfizer, Roche and Novartis rank are the top three in sales, with Pfizer’s sales at $51.8 billion, Roche’s sales at $49.59 billion, and Novartis’ sales at $47.45 billion. Because of changes in regulatory policy and increased pressure from many policies such as Negotiations on Medicare Access, Volume Purchase and Generics Consistency Evaluation, patent-cliff effects emerge quickly, and multinational pharmaceutical companies must develop marketing strategies to maintain increased sales.

Epidemic Prevention
National Health Commission releases sixth trial version of COVID-19 diagnosis and treatment program

On 19 February, 2020, the China National Health Commission released the sixth trial version of COVID-19 diagnosis and treatment program. Key changes to the diagnosis and treatment program include: diagnostic criteria for cases inside and outside Hubei Province are no longer treated differently; additional clinically diagnosed cases in the fifth edition of the diagnosis and treatment plan were cancelled; and many new therapeutic drugs were added to the program with chloroquine phosphate and abidol listed as trial drugs.

Medical Device
NPMA Cancels Medical Device Certificates

According to the National Medical Products Administration (NMPA) “Administrative Measures for the Registration of in Vitro Diagnostic Reagents”, Wallac Oy the registration certificates 20163401511, 20163401510, 20173402164, and 20173402150 have been cancelled. The certificates represent multiple amino acid and carnitine assay kits (tandem mass spectrometry), multiple amino acid and carnitine assay kits (tandem mass spectrometry), 17α-hydroxyprogesterone assay kit (time-resolved fluorescence method), 17α-hydroxyprogesterone Assay kit (time-resolved fluorescence method) respectively.

NPMA Requires Recall of Unqualified Cosmetics

29 batched of hair dye cosmetics were unqualified by the National Medical Products Administration (NMPA) for being in violation of regulations. NPMA requires that they be recalled and removed from shelves, and other related products such as conditioning moisturizing mask, perm, hair cream and skin care products such as soothing toner.

NMPA Accepts Fosun Kite’s New Drug Application (NDA) Filing for Axicabtagene Ciloleucel

On 24 February, 2020, Fosun Kite Biotechnology based in Shanghai announced its New Drug Application (NDA) filing for CD19-directed CAR-T cell therapy Axicabtagene Ciloleucel (FKC876) has been accepted for review by the China National Medical Products Administration (NMPA). Axicabtagene Ciloleucel, FKC876, is an autologous CD19-directed CAR-T cell therapy manufactured in China with the technology of YESCARTA® (Axicabtagene Ciloleucel) transferred from Kite Pharma, a Gilead Company, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma and DLBCL arising from follicular lymphoma.

The principle of autologous CAR-T cell therapy is to genetically modify a patient’s T-cells to express a chimeric antigen receptor (CAR) that will activate T-cells upon engaging cells carrying the specific antigen on the surface. FKC876 targets the B-cell specific antigen CD19 for treating B-cell malignancies. The NDA filing is based on results of a single-arm, open label, multi-center bridging trial (FKC876-2018-001) which evaluated the efficacy and safety of FKC876 in the treatment of patients with refractory intermediate invasive non-Hodgkin’s lymphoma (NHL)/large B-cell lymphoma in China.

Medical Devices
NMPA Proposes Pilot Guidance on Review of COVID-19 Antigen/Antibody Detection Reagent Registration

The China National Medical Products Administration (NMPA) Center for Medical Device Evaluation unveiled trial guidance on Key Points for Technical Review of New Coronavirus Antigen/Antibody Detection Reagent Registration on 25 February, 2020. The guidance is intended to guide applicants in the preparation and writing of registration information for new coronavirus antigen/antibody detection reagents, and provide a reference for the technical review department. The trial balloon is applicable to new coronavirus antigen / antibody detection reagents for the first registration application, which are used for in vitro qualitative detection of new coronavirus antigens / antibodies in samples such as serum, plasma, whole blood, throat swabs, alveolar lavage fluid, sputum or other respiratory secretions.

Fujian Province Medical Security Bureau Issued Official Document about Purchasing Centralized of Drugs

On 26 February, 2020 Fujian Province Medical Security Bureau issued official document about purchasing centralized of drugs in Fujian Province which includes 14 varieties and 22 specifications. Drugs on the purchasing list have several common characteristics, such as main market share, sufficient market competition, mature clinical usage, and the same generic name.

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates February 2020. For general information on Education Initiatives, click hereHighlight posted on February 29th, 2020


Pharmacogenetics: FDA Releases Table of Gene-Drug Interactions

The U.S. Food and Drug Administration (FDA) published a table identifying more than 50 gene-drug interactions are supported by scientific evidence and announced it is considering new approaches to evaluating pharmacogenetic associations. The table also denotes pharmacogenetic associations that may indicate an impact on a drug’s safety or a patient’s response and gene-drug associations for which an impact has not been established.

FDA Finalizes ‘Biological Product’ Definition Ahead of BPCIA Transition

The U.S. Food and Drug Administration (FDA) is amending its definition of “biological product” in line with the statutory definition set by the Biologics Price Competition and Innovation Act (BPCIA). Initially, the BPCIA amended the definition of a “biological product” to include “protein (except any chemically synthesized polypeptide). The FDA now interprets the term “protein” to mean “any alpha amino acid polymer with a specific defined sequence that is greater than 40 amino acids in size.

Drug Approvals: FDA Publishes Dataset of CDER Approvals

The U.S. Food and Drug Administration (FDA) created a compilation of Center for Drug Evaluation and Research (CDER) approvals from 1985 through 2019 to facilitate data accessibility, transparency, and accuracy when researchers seek information about an approved drug. The compilation itself is a downloadable .CSV file containing information on more than 1,000 new molecular entities (NMEs) and new biologics. For each product, the dataset provides the proprietary name, active ingredient/moiety, applicant, application type, application number, dosage form, route of administration, receipt and approval dates, approved indications and uses, designations and whether a priority review voucher was issued or redeemed for the application.

Health Canada Begins Implementing eCTD for Clinical Trial Applications

Health Canada has moved to increasingly accept or require Electronic Common Technical Document (eCTD) submissions in recent years. Health Canada says it will allow eCTD submissions for pre-clinical trial application consult meetings (Pre-CTA), clinical trial applications (CTAs), amendments (CTA-As) and notification (CTA-N), as well as responses and post-clearance data related to any of the aforementioned applications.

ICH E9(R1) and S5(R3) to Take Effect in EU

The European Medicines Agency (EMA) on adopted two International Council for Harmonisation (ICH) guidelines, E9(R1) and ICH S5(R3), with both guidelines set to take effect on 30 July 2020. The E9(R1) addendum presents a framework for defining an appropriate estimand for a clinical trial and conducting sensitivity analyses. With the S5(R3) guideline, ICH sets recommendations for a harmonized approach to assessing nonclinical developmental and reproductive toxicity (DART) testing used to support clinical trials and drug approvals, including study design and evaluation; test system selection; and dose level selection, route of administration and schedule.


Medical Devices
Medtronic Recalls Insulin Pumps

Last November, Medtronic announced the Class I recall, the most serious type of recall, for 322,005 of its U.S.-distributed MiniMed 600 Series Insulin Pumps, Model 630G and 670G after more than 2,000 injuries and one death. Medtronic is recalling the specified insulin pumps due to a missing or broken retainer ring which helps to lock the insulin cartridge into place in the pump’s reservoir compartment.

Rx-to-OTC Switches: FDA Signs Off on Three Drugs

The U.S. Food and Drug Administration (FDA) granted the switch from a prescription drug to an over-the-counter (OTC) product to GlaxoSmithKline’s Voltaren Arthritis Pain (diclofenac sodium topical gel, 1%) for the temporary relief of arthritis pain from osteoarthritis of joints. The other two drug to OTC switches approved were for Alcon’s Pataday Twice Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.1%) and Once Daily Relief (olopatadine HCl ophthalmic solution/drops, 0.2%). Both drugs are for the temporary relief of itchy and red eyes due to pollen, ragweed, grass, animal hair or dander.

Australia Warns Against Products Marketed for Novel Coronavirus

Australia’s Therapeutic Goods Administration (TGA) warned drug makers not to make therapeutic claims related to the novel coronavirus in advertisements for their products. The agency said companies claiming their products can prevent the virus’ spread or increase a patient’s immunity may be subject to sanctions and fines.

Ireland’s NSAI Designated as 11th Notified Body Under MDR

The National Standards Authority of Ireland (NSAI) was added to the European Commission’s NANDO (New version of database of Notified Bodies) database as the 11th notified body and first from Ireland to be designated under the EU’s Medical Devices Regulation (MDR), which takes effect on 26 May, 2020. The designation for the Dublin-based authority is for active implantable devices, active non-implantable devices, non-active implants and long term surgically invasive devices and non-active non-implantable devices, among others.

U.K. Introduces Medicines, Medical Devices Bill in Post-Brexit Overhaul

The U.K. government has introduced a bill just two weeks after Brexit, to update its regulatory framework for human and veterinary medicines, clinical trials and medical devices. The bill would grant the Secretary of State for Health and Social Care the power to impose civil sanctions, in the form of monetary penalties, and share information about medical devices in response to safety issues. The bill would also allow for broader prescribing of low-risk medicines by healthcare professionals and includes provisions to allow hospitals to develop and provide personalized medicines.


FDA Targets Faster Reviews for Biosimilar Supplements

Draft guidance released by the U.S. Food and Drug Administration (FDA) details how the agency cannot license a biosimilar or interchangeable product for an indication protected by orphan-drug exclusivity or pediatric exclusivity until the expiration of that exclusivity. The draft also explains how the proposed labeling for a biosimilar will depend on whether the applicant is seeking licensure for all (or fewer) of the conditions of use licensed for the reference product.

FDA Authorizes Caption Guidance Software

The U.S. Food and Drug Administration (FDA) authorized marketing of the first cardiac ultrasound software that uses artificial intelligence to guide the user. The Caption Guidance software is an accessory to compatible diagnostic ultrasound systems and uses artificial intelligence to help the user capture images of a patient’s heart that are of acceptable diagnostic quality. The FDA reviewed the device through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type.

FDA Classifies NGS HIV Drug Resistance Test into Class II

The U.S. Food and Drug Administration (FDA) issued a final order classifying next generation sequencing (NGS) HIV drug resistance genotyping assays used to aid in monitoring and treating HIV infections into Class II (special controls). The final order codifies the classification under 21 CFR 866.3955 and provides a generic name for the device. In addition, it identifies two risks posed by the assay and provides four mitigation measures for device makers to establish and ensure its safety and effectiveness and avoid automatic classification into Class III.

ICER Unveils New Approach for Cost-Benefit Assessments

The Institute for Clinical and Economic Review (ICER) has updated its drug value assessment process for 2020 to include more real-world evidence (RWE), a one-year reevaluation and other new elements. The update expands the categories of “potential other benefits” to include the level of health loss that would be experienced without the treatment and the mechanism of the action’s similarity to other approved drugs. ICER will launch a pilot program for updating original assessments after a medicine has been on the market for at least two years for drugs approved under the U.S. Food and Drug Administration (FDA) accelerated approval pathway.

Bayer’s Eylea Proves Efficacy, Safety in ALTAIR Study

Bayer has revealed results from its Phase IV ALTAIR study, which evaluated the efficacy and safety of Eylea (aflibercept). According to Dr Jackie Napier, medical director of ophthalmology at Bayer, the study found, when using two different Treat and Extend (T&E) dosing regimens in patients with wet age-related macular degeneration (AMD), allowing greater flexibility of injections in year one, and extension to intervals up to 16 weeks could “provide significant benefits for patients and their caregivers, including fewer medical appointments, reduced waiting lists and an improvement in the overall burden associated with this treatment experience,.”

FDA Update on Metformin NDMA Investigation Rules Out Recalls

The U.S. Food and Drug Administration (FDA) investigated metformin products from seven different drugmakers (Actavis, Aurobindo, Heritage, Ingenus, Major, Sun Pharma and Westminster Pharmaceuticals) for N-Nitrosodimethylamine (NDMA). Of the 16 lots tested, all samples came back clean except for six Actavis lots that tested positive but for very low amounts of NDMA. The FDA said it found no metformin products exceeded daily intake limits of NDMA) so it did not recommend recalling the type 2 oral diabetes drug in the U.S.


FDA Warns Purell to Stop Claiming It Can Prevent Ebola or Flu

The U.S. Food and Drug Administration (FDA) has warned the maker of Purell hand sanitizers to stop claiming its products can prevent people from catching the flu, Ebola virus, the MRSA superbug and norovirus because these unsubstantiated claims violate the Federal Food, Drug and Cosmetic Act. The agency said it is reclassifying Purell as an unapproved drug, rather than an over-the-counter product.

FDA Calls for Bacitracin Products to be Removed from the Market

The U.S. Food and Drug Administration (FDA) requested that all current manufacturers of bacitracin for injection voluntarily withdraw their products from the market. This request of voluntary withdrawal does not impact approved topical or ophthalmic drugs that contain bacitracin. Bacitracin for injection is currently FDA-approved to treat infants with pneumonia and empyema. The FDA noted serious risks from the injections, including nephrotoxicity, anaphylactic reactions and the need for repeated intramuscular injections.

EMA Committee on Medicinal Products for Human Use Recommends Medicines Approvals and Extensions

The European Medicines Agency committee on Medicinal Products for Human Use (CHMP) recommended approval of eight new medicines [Alnylam’s Givlaari (givosiran), Novo Nordisk’s Rybelsus (semaglutide), Emergent’s Vaxchora (Cholera vaccine), Eli Lilly’s Liumjev (insulin lispro), Esperion’s Nilemdo (bempedoic acid) and Nustendi (bempedoic acid/exetimibe), Bayer’s Nubeqa (darolutamide) and Pfizer’s Staquis (crisaborole)], one biosimilar medicine [Pfizer’s Ruxience (rituximab)], and four generic medicines [Azacitidine betapharm (azacytidine), Azacitidine Mylan (azacitidine), Arsenic trioxide Mylan (arsenic trioxide) and Cinacalcet Accordpharma (cinacalcet)]. Extended indications were also recommended for Biofrontera’s Ameluz (5-aminolevulinic acid hydrochloride), Roche’s MabThera (rituximab), Janssen’s Rezolsta (darunavir and cobicistat), Sanofi’s Suliqua (insulin glargine and lixisenatide), Gilead’s Tybost (cobicistat) and AbbVie’s Venclyxto (venetoclax).

FDA Approves First Drug for Treatment of Peanut Allergy for Children

The U.S. Food and Drug Administration (FDA) approved Palforzia [Peanut (Arachis hypogaea) Allergen Powder-dnfp] to mitigate allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts. Treatment with Palforzia may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy. Palforzia is a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for Dose Escalation and Up-Dosing, and in a sachet for maintenance treatment.

CDC to Distribute Diagnostic Kits for Coronavirus

The Centers for Disease Control and Prevention (CDC) polymerase chain reaction diagnostic test for coronavirus takes four to six hours to complete after a sample is prepared. The test is currently focused on respiratory and blood samples. According to Nancy Messonnier, Director of the CDC National Center for Immunization and Respiratory Diseases, the agency aims to distribute the diagnostic kits to every state.

Lawmakers Question FDA on Complex Generic Approvals

The U.S. House Energy and Commerce Committee sent a letter to U.S. Food and Drug Administration (FDA) Commissioner Stephen Hahn calling for details of how the agency has been approving generics that include a complex active pharmaceutical ingredient, formulation, route of delivery, or are part of a complex drug-device combination. The committee noted that complex generics are considered important options for less costly treatment of such conditions as multiple sclerosis, schizophrenia, metastatic breast cancer, osteoporosis and chronic obstructive pulmonary disease, among others.

Revised MAPP Tightens FDA Scope for Prioritized Generic Drug Applications

One of the major changes in recently revised Manual of Policies and Procedures (MAPP) is that U.S. Food and Drug Administration (FDA) will no longer automatically prioritize all abbreviated new drug applications (ANDAs) that contain a paragraph IV certification. For supplements, the FDA will prioritize their reviews if they are “(1) related to a drug shortage or public health emergency; (2) subject to legal requirements; or (3) where a delay would impose an extraordinary hardship on an applicant. The FDA is also requiring applicants to make explicit requests for priority reviews.

FDA Launches President’s Emergency Plan for AIDS Relief (PEPFAR) Drug Database

The new mobile-friendly Emergency Plan for AIDS Relief (PEPFAR) Drug Database will make it easier to look up information about AIDS drugs, such as their labeling, whether they are suitable for pediatric use, where they are made and storage requirements. In addition, the database breaks down the numbers of single ingredient, fixed-dose combination and co-packaged products available to purchase through PEPFAR, as well as approval status for each product.

FDA Commissioner Stresses Importance of Data, Real-World Evidence (RWE) in First All-Hands Meeting

While noting that U.S. Food and Drug Administration (FDA) is operating in a time of “unsurpassed scientific and technological innovation,” Commissioner Stephen Hahn called to unleash the power of data and “to attain more and better data,” according to a transcript of his speech. Commissioner Hahn also stressed the need to build upon the FDA’s Patient-Focused Drug Development initiative so “consumers may be even more informed and aware about the entire lifecycle of products we regulate in order to live more healthy and productive lives.”

FDA Details New User Fee Structure for Biosimilars

The Biosimilar User Fee Act of 2017 (BSUFA II) authorized the collection of three types of fees — product development program fees, application fees and program fees — and eliminated fees for supplements and for establishments. Product development fees include an initial fee, an annual fee and a reactivation fee. The initial fee is due within five days after the U.S. Food and Drug Administration (FDA) grants the first product development meeting for the product or upon submission of an IND application to support a biosimilar application. Annual fees are collected in the next fiscal year after the initial product development fee has been paid. Reactivation fees for sponsors who want to re-join the biological product development (BPD) program will be twice the amount of the annual BPD fee established for that fiscal year. Program fees are assessed annually for each named applicant for each product identified in an application approved as of October 1 of that fiscal year that is not discontinued.

Every term we try to provide our students with international enrichment. Reg. Sci. faculty and students conducted a one-week training program in Tainan, Taiwan, between February 9-14 for students and industries associated with National Cheng Kung University. Our students gained valuable experience in presenting to a global audience by assisting with parts of the teaching program while also learning about the fascinating culture, night life and food of a very special part of the world.

To see highlights of all International Activities, click here.
To view the entire gallery of photos from the event, click here. Highlight posted on February 23rd, 2020

Wonderful visit to ACRO Biomedical

3D Printing of Medical Devices

Great weather! Great afternoon!

Our team and theirs!

Night Market in Tainan

Dr. Richmond teaching in Tainan

Dr. Frances Richmond attended the Asia-Pacific Economic Cooperation (APEC) regulatory harmonization meetings held February 7-8 in Kuala Lumpur, Malaysia. APEC is committed to reducing the dissonance that results in non-tariff trade barriers to the entry of medical products into Asia-Pacific countries. The DK Kim International Center within the USC School of Pharmacy, one of only two APEC Centers of Training Excellence in the Medical Devices sector, will host a training session for international regulators in Los Angeles in early June, 2020. Stay tuned for more information on our upcoming training program.

To see highlights of all International Activities, click here.
For more information on APEC CoRE, email Frances Richmond at fjr(at)
Highlight posted on February 23rd, 2020

APEC Updates for our Center of Excellence

Transportation at the ready for the APEC meetings

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates January 2020. For general information on Education Initiatives, click hereHighlight posted on February 1st, 2020


Lokelma Approved in China for Adult Patients with Hyperkalaemia

The China National Medical Products Administration (NMPA) approved AstraZeneca’s Lokelma (sodium zirconium cyclosilicate) for treatment of adult patients with elevated levels of potassium in their blood. The approval was based on results of four studies in which patients receiving Lokelma experienced a significant reduction of their blood potassium level. The drug is approved in the U.S., Canada and the E.U. for treatment of hyperkalaemia. It is undergoing regulatory review in Japan, with a decision expected in the first half of 2020.

Ibrance Given National Institute for Health and Care Excellence (NICE) Green Light for Breast Cancer

Pfizer has announced approval of Ibrance (palbociclib) by the United Kingdom National Institute for Health and Care Excellence (NICE). The potentially life-extending drug will now be available for patients with hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative, advanced breast cancer, who have already undergone endocrine therapy. Ibrance, which will be available on the Cancer Drugs Fund in combination with fulvestrant, joins two other NICE-approved drugs – Kisqali (ribociclib) and Verzenios (abemaciclib) – as an option at this stage of the treatment pathway. Pfizer says that because of the approval, the treatment could be an option for up to 3,300 women who have already had endocrine treatment and where exemestane plus everolimus would be the most appropriate alternative to a CDK 4/6 inhibitor.

U.S. FDA Approves Blueprint’s Therapy for Rare Type of Stomach Cancer

The oral drug, Ayvakit, by Blueprint, is the first treatment approved by the U.S. Food and Drug Administration (FDA) for a small subset of patients with a mutation of gastrointestinal stromal tumor (GIST) cancer. Blueprint is also pursuing FDA approval for use of Ayvakit in patients in advanced stages of GIST who have exhausted all other options of care – a much larger population of patients. According to the company, Ayvakit is having significant impact on shrinking patient tumors and keeping them disease progression free for very long periods of time. GIST patients who have undergone surgery are typically given Novartis AG’s Gleevec for twelve months in an effort to delay the spread or recurrence of cancer. However, the drug has not been effective in treating patients with the mutation targeted by Ayvakit.

FDA Warns of Potential Cancer Risk with Weight Loss Drug

The U.S. Food and Drug Administration (FDA) on Tuesday alerted the public to results from a clinical trial that showed a possible increased risk of cancer with Eisai’s weight management drug Belviq (lorcaserin), including the extended release version. The cause of the cancer is unclear, and the FDA cannot conclude if lorcaserin contributes to the cancer risk. The FDA wanted to make the public aware of the concern and will continue to evaluate the clinical trial results.

Celgene Backs Out of $55 Million Revlimid Settlement

Celgene has backed out of a class-action lawsuit in the U.S. District Court for New Jersey that alleges that it illegally blocked generic versions of Revlimidcancer treatments by refusing to sell samples to generic manufacturers and fraudulently obtaining patents to obstruct generic competition and filing litigation against generic drugmakers to stop their proposed generics from reaching market. The decision leaves Celgene to deal with more than 9,000 plaintiffs.

FDA Offers Q&As on Submission of Initial Pediatric Study Plans (iPSPs) for Cancer Drugs

The U.S. Food and Drug Administration (FDA) released a  draft document, the form of questions and answers (Q&As), discussing everything from when an Initial Pediatric Study Plans (iPSPs) for cancer drugs are required, to when an iPSP can be abbreviated for sponsors seeking a waiver, to whether sponsors of combination drugs need to submit separate iPSPs for each of the drugs in the combination.

On or after 18 August 2020, the Q&A says sponsors of original or supplemental applications seeking a full waiver of pediatric studies for cancer drugs containing a new active ingredient, including for products directed at a molecular target included on FDA’s list of ”Non-Relevant Molecular Targets which Warrant Waiver”, should also submit an abbreviated iPSP as described in the 2016 draft guidance. Even for products whose marketing applications are likely to be submitted before August 18, 2020, FDA recommends submission of an iPSP and early discussion with the agency prior to application submission which may facilitate the development of studies to ensure that all relevant Pediatric Research Equity Act requirements are met.

FDA to Allow Online Submissions of Orphan Designation Requests

The U.S. Food and Drug Administration (FDA) announced that later this year it will move from a paper-based process to a new cloud-based online submission portal for orphan drug designation requests. The Orphan Drug Technology Modernization effort will allow for a more connected information technology system, advanced analytics, and improvements in facilitating knowledge management. In addition, it will provide external sponsors with more efficient submission of documents and enhanced direct communication with the FDA.

EU-China Working Group to Address API Manufacturing Concerns

The China National Medical Products Administration (NMPA) has agreed to work with the European Commission Directorate-General for Health and Food Safety, European Medicines Agency (EMA) and others to identify common ground between China and E.U. regulatory systems for active pharmaceutical ingredient (APIs). The European Commission says it has conducted a gap analysis, which would be used to identify Chinese training needs in the API space. E.U. experts will also conduct a fact-finding visit to China to assess the regulatory, control and enforcement system governing implementation of Good Manufacturing Practice standards. The commission also says it has contacted the U.S. Food and Drug Administration (FDA) for a project on a joint training plan for inspectors from India and China of API manufacturing sites. Information on recent inspection trainings in China and India were requested by EMA, FDA, Japanese Ministry of Health & Welfare and the World Health Organization.

Quality Systems
FDA Recognizes New Version of ISO 14971

The newly revised International Organization for Standardization (ISO) risk management standard for medical devices, ISO 14971:2019, are wide ranging, covering topics such as anesthesiology, biocompatibility, materials, physical medicine, radiology, software and sterility. As for the transition to ISO 14971:2019, the U.S. Food and Drug Administration (FDA) announced it will still accept declarations of conformity to the previous version, ISO 14971:2007, in support of premarket submissions until 25 December 2022.

MAPP Further Explains FDA Process for Reviewing REMS Assessment Reports

The U.S. Food and Drug Administration (FDA) last month offered a new Manual of Policies and Procedures (MAPP), effective 18 December 2019, to explain how the Center for Drug Evaluation and Research (CDER) reviews risk evaluation and mitigation strategy (REMS) assessment reports submitted to the agency.

Clinical Decision Support (CDS) Software: Stakeholders Seek More Clarity from FDA Draft Guidance

The U.S. Food and Drug Administration (FDA) released clarification on the categories of CDS software subject to agency oversight, as well as low-risk categories of CDS software for which FDA does not intend to enforce regulatory requirements and CDS categories that do not meet the definition of a device. It remains unclear what regulatory recommendations should be considered when using CDS that is not 510K cleared in a clinical trial and when the use is for a critical or serious condition


Gilead Claims Truvada Patents in HHS Complaint are Invalid

The U.S. Department of Health and Human Services (HHS) took the rare step of filing a complaint against Gilead for infringing on government-owned patents related to the HIV drug Truvada for pre-exposure prophylaxis (PrEP). The HHS complaint explained how Gilead had failed to address  that the Centers for Disease Control and Prevention (CDC) “is widely acknowledged as being the first to demonstrate that FTC/tenofovir prodrug regimens are highly effective in preventing HIV infections and resulted in immediate changes to large human trials related to Truvada for PrEP. These trials directly led to FDA approval of that regimen.” Gilead filed its retort, indicating that it does not believe it has infringed on the CDC Truvada patents because they are invalid.

FDA Approves First Treatment Option Specifically for Patients with Epithelioid Sarcoma, a Rare Soft Tissue Cancer

The U.S. Food and Drug Administration (FDA) granted accelerated approval to Tazverik (tazemetostat) for the treatment of adult and pediatric (aged 16 years and older) patients with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection. Tazverik also received an orphan drug designation. In the clinical trial, the overall response rate was 15%, with 1.6% of patients having complete response and 13% having a partial response. Of nine patients that had a response, six patients had a response lasting six months or longer.

Drug-Drug Interactions: FDA Issues Guidance on Clinical, In Vitro Studies

The U.S. Food and Drug Administration (FDA) finalized two guidance recommendations to drugmakers on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing. The FDA In Vitro Drug Interaction Studies guidance discusses approaches to evaluate the DDI potential of investigational drugs and how those studies can inform clinical DDI studies. In Clinical Drug Interaction Studies, the FDA explains when DDI studies should be conducted and provides recommendations for the design, conduct and interpretation of those studies.

FDA Finalizes 2018 Guidance on Use of Minimal Residual Disease

The U.S. Food and Drug Administration (FDA) finalized guidance to help sponsors planning to use minimal residual disease (MRD) as a biomarker in clinical trials for treating specific hematologic malignancies. The guidance discusses technology that can detect the persistence of malignancy. These technologies measure cell characteristics such as genetic mutations, cell surface markers, or specific DNA gene rearrangements. Depending on the clinical setting, MRD may be used to reflect a patient’s response to treatment or as a prognostic tool to assess a patient’s risk of future relapse.

FDA Issues Guidance on Clinical, In Vitro Studies

The U.S. Food and Drug Administration (FDA) finalized two guidance documents providing recommendations to drug makers on evaluating potential drug-drug interactions (DDIs) for new drugs through clinical and in vitro testing. The two final guidance describe a systematic risk-based approach to evaluation and communication of DDIs. Additionally, the guidance discusses different DDI study designs and considerations for prospective DDI studies.

CMA Pins Down Tiofarma for Illegal Market Sharing

The U.K. Competition and Markets Authority (CMA) provisionally found that three drug firms – Aspen, Amilco and Tiofarma – signed an illegal agreement that resulted in significant price hikes for an essential medicine. The drug in question – fludrocortisone – is a life-saving medicine that thousands of patients rely on to treat adrenal insufficiency, commonly known as Addison’s Disease. The CMA announced that it alleges, and provisionally found, that the agreement between Aspen, Tiofarma and Amilco contributed to the price of fludrocortisone acetate tablets supplied to the National Health Service increasing by up to 1800%. Tiofarma has agreed to pay a maximum fine of £186,000 if there is a formal final decision that the law has been broken. However, Amilco has made no admission of liability and so the CMA probe is ongoing.

Sarepta Got a Scathing Rejection from the FDA

The U.S. Food and Drug Administration (FDA) rejected Sarepta’s application for golodirsen. The rejection was scathing, focusing on a number of reported infections related to administration of eteplirsen, another Sarepta drug for Duchenne muscular dystrophy. The FDA called into question the benefit of golodirsen and criticized Sarepta for not running a confirmatory trial required under the terms of approval of eteplirsen. The newly revealed details of the regulatory exchange appear to be raising concerns about the fate of casimersen, a third drug for Duchenne muscular dystrophy, which the company said on January 13, 2020 it had begun to submit for FDA approval on a rolling basis.

Brexit Withdrawal Signed Ahead of UK’s 31 January Departure

Presidents of the European Commission and European Council and U.K. Prime Minister Boris Johnson on 24 January 2020, signed a withdrawal agreement that will see the U.K. continue to follow E.U. rules through the end of the year while seeking a deal for future ties with the E.U. The European Medicines Agency and the European Commission have provided a collection of guidance documents for drugmakers to follow to ensure their products are in compliance, post-Brexit. For the U.K., the Medicines and Healthcare products Regulatory Agency (MHRA) has compiled a set of guidance documents and publications covering drug and medical device regulation in the U.K. in the event that a Brexit deal is not reached. For medical devices and in vitro diagnostics, the current EU directives will still apply to the U.K. via the Medical Devices Regulations 2002 as amended by The Medical Devices (Amendments etc.) (EU Exit) Regulations 2019, which transpose the upcoming E.U. Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) into U.K. law.

EMA to Use ISO International Format for Reporting Individual Side Effects

The European Medicines Agency announced that starting in June 2022, side effects will need to be submitted to the EudraVigilance safety monitoring system using the individual case safety report (ICSR) format, which provides a common set of data points for adverse drug reactions, adverse events, infections and incidents that can occur from drug administration. The new format will generate higher quality, easier-to-analyze data that “will better support regulatory authorities and companies to detect and address safety issues with medicines and therefore protect patients,” the agency said.

Medical Devices
FDA Warns of Cyber Risks with Certain GE Devices  

The U.S. Food and Drug Administration (FDA) issued a cyber risk warning concerning GE’s Clinical Information Central Stations and Telemetry Servers, which the FDA says are mostly used for displaying information such as a patient’s temperature, heartbeat and blood pressure, as well as monitoring a patient’s status from a central location in a facility, such as a nurse’s workstation. GE said there have been no reported cyberattacks or any reported injuries associated with any of these vulnerabilities. The company also said the devices can continue to be used and hospitals should properly configure the devices’ Mission Critical (MC) and/or Information Exchange (IX) networks to ensure their isolation and prevent hacking.

Quality Systems
FDA Warns N.J. Drugmaker for Subpar Quality Unit

The New Jersey drugmaker Health Pharma USA drew a warning letter from the U.S. Food and Drug Administration (FDA) because an agency inspection of the facility revealed that the quality unit wasn’t making sure that its products met identity, strength, quality and purity requirements. Specifically, the agency called out the drugmaker for shipping products before the quality unit reviewed them, noting one lot of aspirin 81 mg that was shipped before final quality review, and lots of aspirin 81 mg and acetaminophen 325mg were delivered despite incomplete quality testing. The agency also flagged inadequate process validations for aspirin and acetaminophen products, and not routinely performing identity testing for incoming product components.

Dr. C. Benson Kuo and his team are documenting the evolving regulatory landscape in China! For general information on Education Initiatives, click hereHighlight posted on February 1st, 2020

Medical Devices
The Medical Device Unique Device Identification (UDI) System is Coming to China

On December 10, 2019 the Unique Device Identification (UDI) system was launched in China in accordance with requirements of ‘Unique Device Identification System Rules’ and ‘Unique Device Identification System Pilot Work Plan’. The UDI system is now open to enterprises to submit UDI related data of their medical devices. Liaoning Province is in the first batch of pilot areas to implement the UDI system with high-risk implantable medical devices such as heart and orthopedic products produced in the province becoming the first batch of pilot submittals. When the UDI system is fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device post-market surveillance, and facilitate medical device innovation.

Agalsidase Beta for Injection Approved in China for Patients with Rare Fabry Disease

Recently, the China National Medical Products Administration (NMPA) has approved Agalsidase Beta for Injection (trade name: Fabrazyme), which is the first drug approved in China for the treatment of Fabry disease, a rare genetic disease caused by the deficiency of alpha-galactosidase enzyme A. Fabrazyme  suitable for children over the age of 8, adolescents and adults.
The approval is based on the results of overseas clinical trial data, combined with the effectiveness and safety characteristic of the product. Fabrazyme was declared by Sanofi (China) Investment Co., Ltd on behalf of Genzyme Europe B.V., and has been listed in the second batch of NMPA clinically urgently needed new drugs and included it in priority review varieties.

Public Announcement of the Second Round of National Procurement

On January 17, 2020, under the guidance the National Medical Insurance Bureau, the Joint Procurement Office announced winning results of the second batch of national centralized procurement of drugs: A total of 32 varieties were purchased, and a total of 100 products were selected. 122 companies participated in the bidding, resulting in 77 companies being awarded. Compared with 2018 purchase prices, the average price of the proposed bid decreased by 53%. Levocetirizine produced by Jiudian Pharmaceutical had the highest decline by 97.44% and for the “blockbuster” hypoglycemic drugs – Acarbose,Bayer lowered the price 0.8353 CNY/tablet. The reduced prices will help medicare funds to incorporate drugs with more curative effect.

NMPA: Continue Marketing New Drugs and Good Drugs, Promote Consistency Evaluation of Generics

On January 18-19, 2020, the National Conference on Drug Registration Management and Post-Marketing Supervision was held in Beijing, China. At the meeting the China’s National Medical Products Administration (NMPA requested the continued marketing of new drugs and good drugs and promoting consistency in the evaluation of generic drugs. Key tasks for drug registration management in 2020 included:  coordination of national drug registration management work; comprehensive promotion of revision of supporting documents for the newly revised Measures for the Administration of Drug Registration; reforms to the management of Chinese medicine registration; and to promote the inheritance and innovative development of Chinese medicine.

China Approves First ACD Drug

On Jan 21, 2020, Trastuzumab emtansine (trade name Kadcyla) produced by Roche has been approved by the China National Medical Products Administration (NMPA). The Antibody-Conjugated Drug (ACD) fills the gap in the treatment for patients with HER2-positive breast cancer in China who have not achieved complete pathological remission (pCR) after neoadjuvant therapy. Although Kadcyla was first approved by the U.S. Food and Drug Administration (FDA) in February 2013, the new indication approved in China was approved by the FDA and E.U. European Medicines Agency (EMA) in May 2019 and December 2019, respectively. Simultaneous approval with the E.U. and U.S. provides a new option for Chinese patients with HER2-positive early breast cancer and allows Chinese patients to use international innovative drugs as soon as possible.

National Medical Insurance Bureau Issues Special Reimbursement Policy for Novel Coronavirus

Recently, novel coronavirus broke out in China. Against this emergency, The China National Medical Insurance Bureau has issued a special reimbursement policy All medicines and medical service items covered by the ‘New Coronavirus Infected Pneumonia Diagnosis and Treatment Program’ will be temporarily included in the medical insurance fund payment scope, guaranteeing patients’ payment in time. With regard to hospitals under centralized treatment, the government will prepay medical funds to reduce financial stress on these hospitals.

Medical Devices
Four New Coronavirus Nucleic Acid Detection Kits Approved by NMPA for Emergency Response

On January 26, 2020, the China National Medical Products Administration (NMPA) approved four new coronavirus detection kits from four companies (Shanghai ZJ Bio-Tech Co., Ltd, Shanghai GENEODX, BGI Genomics, and MGI Tech Co., Ltd), expanding the supply of new coronavirus detection reagents, to better serve the needs of epidemic prevention and control. Immediately after the outbreak, the NMPA initiated the emergency approval process for medical devices and expedited the review and approval process. Currently, four products including the new coronavirus 2019-nCoV nucleic acid detection kit (fluorescent PCR method) and the 2019 new coronavirus nucleic acid sequencing system have been approved. At the same time, provincial drug regulatory departments have been required to strengthen supervision and inspection of the above-mentioned product manufacturing enterprises to ensure product quality and safety. NMPA will continue to adopt special approval procedures for drugs and medical devices needed for epidemic prevention and control and strive for relevant products to be listed as quickly as possible.

RegSC joined numerous student led clubs and organizations at Alumni Park on Trousdale Parkway on Thursday, January 9 for Involvement Fair 2020. Club President Annie Ly planned and coordinated RegSC’s involvement at the Fair. Christian Reyes and Advaita Chandramohan, enthusiastic club members, problem-solvers and leaders, volunteered to engage the next generation of regulatory science leaders. RegSC is dedicated to fostering student interest in regulatory science through collaborations with graduate students and faculty on research projects, training symposiums, and participation in academic and professional conferences. In addition, members attain “soft” skills and experience with developing research posters and abstracts. Thanks RegSC team!

For general information on Research Activities, click here.
Highlight posted on January 20th, 2020



Accordion Content

All of us here at the Department of Regulatory and Quality Sciences wish you a happy and safe holiday season.  See you in 2021!

Click the image below or HERE to view our holiday book of recipes, drinks, and good cheer!

A link to the recording of the Student Orientation session for our department is not posted on the Student Links page.  Meet some of our faculty and staff, and find out why we have such a great program!

The world of Drug Safety and Pharmacovigilance is undergoing dramatic change from simple adverse event reporting to comprehensive signal and benefit-risk management processes. In this course, attendees will be introduced to the core aspects of best practices by industry experts.

The short course will mix its lectures with practical demonstrations and roundtable discussions. It will address and advise on the interactions between different processes and groups that must be managed by a modern Drug Safety Department.

To register and see the agenda, go to THIS PAGE.

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Significant changes in EU medical device regulations and procedures are impacting the development of new and continued compliance of existing devices in the European market. This short course will describe major elements of the new regulatory paradigm, including economic operators, hazardous substances, software under MDR, working with notified bodies, clinical requirements under the new regulations, standards, unique device identification, labeling and implant card, and technical requirements.

It will also cover special topics such as the impact of MDR on the regulation of pharmaceutical products in the EU and “cosmetic” products. The consequences of the recent COVID-19 pandemic on the implementation of the MDR will be discussed.

Now registered participants can go to THIS PAGE to download the e-binder and other resources.  You MUST have the password provided by USC RegSci.

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Sit down face-to-face with Industry Professionals, and find out about opportunities in your field!  Current students and alumni are invited to attend!

Register HERE to attend our Spring Career Event.

Wonder what graduate-level science courses are like? Interested in a career in the medical device space, pharmaceuticals, or biotechnology? Register to sit in on a graduate-level course, RSCI 606: Regulation of Emerging Technologies and Biological Products, and meet with faculty who teach in the Pharmacy Undergraduate Program as well as the Graduate programs for Regulatory and Quality Sciences. Lunch will be provided!

If you have any questions, please feel free to reach out to Amelia Lamorin at


Join us for a full day covering the latest developments regarding medical device innovation, regulations, and policies. Experts will discuss digital intricacies involved in medical product development, artificial intelligence, machine learning, clinical virtual reality, the regulatory framework of the digital world, and cybersecurity!

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Interested in a degree in regulatory science, or know someone who is? Join the USC Department of Regulatory and Quality Sciences for our upcoming virtual information session!

Register Here