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24 March 2022

Generic Drug Science and Research Initiatives Public Workshop

2022 FDA Generic Drug Science and Research Initiatives Public Workshop

US FDA will host a free virtual public workshop on May 9 – 10, 2022 on Generic Drug Science and Research Initiatives.

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 fulfils 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.

More about this workshop and how to registrar for this event: