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The U.S. Food and Drug Administration is hosting a hybrid public meeting on September 16, 2026, to discuss proposed recommendations for reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 to 2032. View the proposed PDUFA VIII commitment letter. PDUFA amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires at the end of September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees for future fiscal years. Visit the event webpage to register for the meeting, request to make a verbal statement during the public comment session of the public meeting, or find additional details. FDA must receive requests to provide public comment at the meeting by September 2, 2026. FDA also invites written comments and feedback to the public docket as the agency continues the process to reauthorize the program in FYs 2028 to 2032. The comment period will close on October 16. You may make public comments to the docket via the Federal Register.
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