For Industry

GDUFA Reauthorization Public Meetings

GDUFA Public Meeting - October 21, 2016

The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold a public meeting following negotiations between the Agency and the generic drug industry. The purpose of the public meeting is to provide an opportunity for the public to present its views on the proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA). After consideration of the views expressed by the public in presentations at the public meeting and comments submitted to the docket, FDA will, as necessary, revise the recommendations.

On October 21, 2016, FDA will hold a public meeting to seek input on the reauthorization of GDUFA. The comment period for the GDUFA public meeting docket will be open from September 26, 2016 through November 16, 2016.

Meeting Materials

GDUFA Public Meeting - June 15, 2015

The FD&C Act requires that prior to beginning negotiations with the generic drug industry, FDA hold a public meeting at which the public may present its views on the reauthorization. On June 15, 2015, FDA held a public meeting to seek input on the reauthorization of GDUFA.

Meeting Materials


Page Last Updated: 10/14/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English