Tuesday, March 23, 2021

Updated Date for FY 2021 Generic Drug Science and Research Initiatives Public Workshop

CDER SBIA Webinar Registration

FDA | CDER | Small Business and Industry Assistance

CONFERENCES

FY 2021 Generic Drug Science and Research Initiatives Public Workshop

June 23, 2021

This workshop is FREE.


Registration

This public workshop will provide an overview of the status of current science and research initiatives for generic drugs and an opportunity for public input on these initiatives. FDA will take the information it obtains from the public workshop into account in developing its FY 2022 GDUFA Science and Research Priority Initiatives.

BREAKOUT SESSIONS

The workshop will include interactive breakout sessions on the following topics:

  • Model-Integrated Evidence for Generic Drug Development
  • Complex Product Characterization and Analysis
  • In Vitro and In Vivo Bioequivalence Approaches: Challenges and Opportunities

WE WANT TO HEAR FROM YOU

FDA seeks suggestions for generic drug research topics from a variety of stakeholders––industry, academia, patient advocates, professional societies, and other interested parties. Submit your potential topics and suggestions for the FY 2022 GDUFA Science and Research Priorities to the public docket number FDA-2017-N-6644.

When registering for the event you may indicate which breakout session you would like to attend.  

AUDIENCE

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


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