Workshop
Event Title
FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop
May 4, 2020
- Date:
- May 4, 2020
Meeting Information
- Date: Monday, May 4, 2020, from 8:30 - 4:30pm
Overview
FDA held a science-focused public workshop to provide an overview of the status of the current FY 2020 Generic Drug User Fee Amendments (GDUFA) Science and Research Priorities as well as solicit input on the development of next year’s (FY 2021) priorities.
This workshop is an integral part of the agency’s GDUFA commitments. We will carefully consider the input provided at the public workshop when we develop the FY 2021 GDUFA Science and Research Priorities. These priorities support product-specific guidance development, the review of Abbreviated New Drug Application (ANDA) submissions, and the pre-ANDA program outlined in the GDUFA commitment letter.
This year’s workshop introduces two exciting new opportunities:
- Virtual Attendance
- Industry Leaders’ Roundtable - Join us for a discussion with industry leaders about the current landscape of FDA’s research program and their perspective on various topics related to generic drug development.
- Breakout Sessions! There were four concurrent breakout sessions on the following topic areas:
- Post-Market Surveillance of Generic Drugs
- Drug-Device Combination Products
- In Vitro Bioequivalence Methods
- Data Analysis and Model-Based Bioequivalence
FDA wants your input.
FDA seeks ideas on generic drug research topics from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties. You may submit your ideas for potential topics for the FY 2021 GDUFA Science and Research Priorities by submitting a comment on the public docket.
Workshop Recordings
- General Session Part 1
- General Session Part 2
- Breakout Session 1: Post-market Surveillance of Generic Drugs
- Breakout Session 2: Combination Products
- Breakout Session 3: In Vitro Bioequivalence Methods
- Breakout Session 4: Data Analysis and Model-Based Bioequivalence
- General Session Part 3
Presentations
General Session
|
Title |
Presenter |
|
Sally Choe, PhD, Director, Office of Generic Drugs |
|
|
Robert Lionberger, PhD, Director, Office of Research and Standards, Office of Generic Drugs |
|
|
Postmarket Surveillance of Generic Drugs: Opportunities for GDUFA Research |
Howard Chazin, MD, Director, Clinical Safety Surveillance Staff, Office of Generic Drugs |
|
GDUFA Regulatory Science and Research on Generic Drug-Device Combination Products |
Kimberly Witzmann, MD, Acting Deputy Director, Office of Bioequivalence, Office of Generic Drugs |
|
GDUFA Regulatory Science and Research on In Vitro Bioequivalence Methods |
Darby Kozak, PhD, Acting Deputy Director, Division of Therapeutic Performance, Office of Research and Standards, Office of Generic Drugs |
|
Quantitative Methods and Modeling to Support GDUFA Regulatory Science Research Program |
Liang Zhao, PhD, Director, Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs |
|
Newly Approved Complex Drug Products and Potential Challenges to Generic Drug Development |
Lei Zhang, PhD, Deputy Director, Office of Research and Standards, Office of Generic Drugs |