FDA: PDUFA Reauthorization Public Meeting (2026)

Government Record · U.S. Food and Drug Administration · August 14, 2026

FDA, August 2026: opened the process to renew the drug user fee program for 2028 to 2032. FDA notes that without new legislation it can no longer collect the fees that fund drug reviews when the current program ends in September 2027. A proposal, not a law.

The current authorization of the program (PDUFA VII) expires in September 2027. Without new legislation, FDA will no longer be able to collect user fees for future fiscal years to fund the process for the review of human drug applications.

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FDA, August 2026: opened the process to renew the drug user fee program for 2028 to 2032. FDA notes that without new legislation it can no longer collect the fees that fund drug reviews when the current program ends in September 2027. A proposal, not a law.

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