FY 2021 Generic Drug Science and Research Initiatives
Public Workshop
June 23, 2021
The purpose of the public workshop is to provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. The public workshop also fulfills FDA’s commitment under the Generic Drug User Fee Amendments of 2017 (GDUFA II) to develop an annual list of science and research initiatives specific to generic drugs. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 GDUFA Science and Research Priority Initiatives.
The workshop includes three interactive breakout sessions with speakers from the generic drug industry and a panel discussion.
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The Agenda provides details on the topics, speakers, and panelists in the Workshop |
The speaker biographies document provides information on the Workshop’s speakers and panelists. |
Session Recordings:
Links to recordings will be added here as they become available.
- Keynote and Industry Survey Results, 8:15 – 9:45
- Generic Industry Challenge Perspectives, 10:00 – 11:15
- Prepared Public Comments, 11:15 – 11:35
- Generic Industry Perspectives Panel Discussion, 12:30 – 1:20
- Breakout Session #1: Model-Integrated Evidence for Generic Drug Development
- Sub-Session 1A, 1:30 – 2:20
- Sub-Session 1B, 2:30 – 3:20
- Sub-Session 1C, 3:30 – 4:30
- Breakout Session #2: Complex Product Characterization/Analysis
- Sub-Session 2A, 1:30 – 2:00
- Sub-Session 2B, 2:10 – 2:40
- Sub-Session 2C, 2:50 – 4:30
- Breakout Session #3: In Vitro & In Vivo BE Approaches: Challenges & Opportunities
- Sub-Session 3A, 1:30 – 2:50
- Sub-Session 3B, 3:10 – 4:30
- Closing Remarks, 4:30 – 4:45
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