---

---

• Location: Virtual via Zoom

About This Workshop

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 future GDUFA Science and Research Initiatives.

This year’s workshop will have the follow sessions:

• The Next Five Years of the GDUFA Research Program
  Perspectives about priority areas for research during the next five years of the GDUFA science and research program from the generic drug industry.
   
• Implementing Practical and Efficient Model-Integrated Bioequivalence Approaches
  Discussion of research priorities to facilitate the practical implementation of approaches using artificial intelligence, model master files, and model-integrated evidence to support demonstrations of bioequivalence.
   
• Excipient Effects Relevant to Generic Drug Products
  Discussion of research priorities for excipient characterization, identification, or classification, as well as for strategies to mitigate the formation of or contamination by impurities such as nitrosamines.
   
• The Global Nature of the Generic Drug Industry
  Discussion of research priorities relevant to the global nature of the generic drug industry, including scientific issues and barriers to the alignment of international bioequivalence recommendations and study designs.
   
• Implementing GDUFA Science in Product Development and Abbreviated New Drug Applications
  Discussion of research priorities to facilitate the practical implementation of GDUFA science and research outcomes in a manner feasible for generic drug development and compatible with regulatory expectations.
   
• Generic Drug-Device Combination Products
  Discussion of research priorities to address common challenges with developing generic drug-device combination products, and exploration of possible solutions to overcome some of those challenges. 

There will also be several panel discussions with members from FDA and the generic drug industry, and an open comment session where attendees will be able to provide comments live during the event. Specific presentations and discussions at this workshop will be announced at a later date.

Audience

Members of the generic drug industry, scientists/researchers, clinicians, regulatory affairs professionals, and patient advocates who work on or are interested in research that advances the development of generic drugs.

FDA wants your input

FDA seeks ideas on generic drug research topics from the drug industry, academia, patient advocates, professional societies, and other interested parties. FDA is particularly interested in receiving public input about the next five years of the GDUFA Science and Research Program. You may submit your ideas for potential topics for the FY 2023 GDUFA Science and Research Priorities by submitting a comment on the public docket: FDA-2017-N-6644

Event Materials

• FY22 GDUFA Public Workshop - Final Agenda (PDF - 221.56 MB)
• FY22 GDUFA Workshop Headshots and Bios (PDF - 1.89 MB)
• FY22 GDUFA Public Workshop Transcript (PDF - 2.4 MB)
• Opening Remarks & Welcome
• Session 1: The Next 5 Years of the Generic Product Science and Research Program
• Session 2: Implementing Practical and Efficient Model-Integrated BE Approaches
• Session 3: Public Comments
• Session 4: Excipient Effects
• Session 5: The Global Nature of the Generic Drug Industry
• Session 6: Implementing GDUFA Science in Product Development and ANDAs
• Session 7: Drug-Device Combination Products
• Session 8: Panel Discussion on The Next 5 Years
• Closing