For Industry

GDUFA Reauthorization Public Meeting

On June 15, 2015, FDA held a public meeting to seek input on the reauthorization of the Generic Drug User Fee Amendments of 2012 (GDUFA).The legislative authority for GDUFA expires at the end of September 2017. At that time, new legislation will be required for FDA to continue to collect generic drug user fees for future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA hold public meetings and conduct discussions with both the generic drug industry and patient and consumer advocacy groups in developing recommendations for the next GDUFA program (FY2018-2022).

The comment period for the GDUFA public meeting docket was open from April 21, 2015 through July 15, 2015.

For more information and the latest events regarding GDUFA, please visit our Generic Drug User Fee Amendments of 2012 website.


Page Last Updated: 12/16/2015
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