For Industry

GDUFA Reauthorization Stakeholder Meetings

The Federal Food, Drug, and Cosmetic Act (FD&C Act) directs the Food and Drug Administration (FDA) to hold monthly discussions with representatives of patient and consumer advocacy groups during negotiations with the generic drug industry on reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA) program. FDA held the first stakeholder meeting on October 19, 2015. Meeting minutes will be posted on the FDA Web site approximately 20 business days after each session.

FDA invites representatives of patient and consumer advocacy groups who wish to participate in these monthly discussions to notify the Agency by email to On August 12, 2015, FDA published a Federal Register notice extending the notification and comment period to April 30, 2016. Your email should contain complete contact information, including name, title, affiliation, address, email address, phone number, and notice of any special accommodations required because of a disability.


2015 Stakeholder Meeting Materials 

August 31, 2016 Stakeholder Meeting Materials

July 28, 2016 Stakeholder Meeting Materials

June 30, 2016, Stakeholder Meeting Materials

May 17, 2016, Stakeholder Meeting Materials

April 12, 2016, Stakeholder Meeting Materials

March 23, 2016, Stakeholder Meeting Materials

February 24, 2016, Stakeholder Meeting Materials

January 27, 2016, Stakeholder Meeting Materials

Page Last Updated: 09/16/2016
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