For Industry

GDUFA Reauthorization Public Meetings

In accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), the FDA held two public meetings related to the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). Each meeting was announced in the Federal Register along with the opening of a docket to allow public comments. The first meeting was held on June 15, 2015, prior to negotiations with industry, to allow the public to present its views on the reauthorization, including specific suggestions for changes. The second meeting was held on October 21, 2016, after negotiations with industry, to allow the public an opportunity to see and comment on the recommendations developed by FDA and industry prior to the recommendations being sent forward to Congress. Information related to both public meetings is provided below.

GDUFA Public Meeting - October 21, 2016

Meeting Materials

Comments Submitted to the October 21, 2016 GDUFA Public Meeting Docket (FDA-2012-N-0882-0042)

FDA Analysis of Public Comments (PDF - 240KB)

GDUFA Public Meeting - June 15, 2015

Meeting Materials

Comments Submitted to the June 15, 2015 GDUFA Public Meeting Docket (FDA-2012-N-0882-0002)


Page Last Updated: 01/09/2017
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