GDUFA Reauthorization Negotiation Sessions
In accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Food and Drug Administration (FDA) held negotiations with the generic drug industry on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) program. The FDA publishes all negotiation meeting minutes on this website.
FDA-Industry Negotiations Meeting Minutes
- August 24, 2016 Session
- July 25, 2016 Session
- July 13, 2016 Session
- July 12, 2016 Session
- July 7, 2016 Session
- July 6, 2016 Session
- June 28, 2016 Session
- June 14, 2016 Session
- May 12, 2016 Session
- April 28, 2016 Session
- April 27, 2016 Session
- April 20, 2016 Session
- April 14, 2016 Session
- April 6, 2016 Session
- April 5, 2016 Session
- March 31, 2016 Session
- March 30, 2016 Session
- March 16, 2016 Session
- February 17, 2016 Session
- February 3, 2016 Session
- January 20, 2016 Session
- January 6, 2016 Session
- December 16, 2015 Session
- December 2, 2015 Session
- November 18, 2015 Session
- November 5, 2015 Session
- October 21, 2015 Session
- October 7, 2015 Session
Fee Modeling Subgroup
- August 4, 2016 Session
- July 26, 2016 Session
- July 25, 2016 Session
- July 22, 2016 Session
- June 30, 2016 Session
- June 28, 2016 Session