Public Meeting on the Reauthorization of GDUFA
About this Event
The Food and Drug Administration (FDA or Agency) is hosting a hybrid public meeting on September 17, 2026 to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032.
GDUFA authorizes FDA to collect user fees for the process for the review of human generic drugs. The current legislative authority for GDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA publish a notice in the Federal Register requesting public input on proposed recommendations and hold a public meeting where the public may present its views on the recommendations. FDA also invites public comment as the Agency continues the process to reauthorize the program in FYs 2028 - 2032. The comment period will close on October 17.
There will be an opportunity for stakeholders to provide comments during an Public Stakeholder Perspectives session at the end of the meeting. Registrants for the meeting will receive information on how to register to provide comments in their confirmation email.
As they become available, additional information (e.g. the Federal Register notice, the meeting agenda) will be provided at this link: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-reauthorization-generic-drug-user-fee-amendments-gdufa-09172026
Where is it happening?
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