In September 2022, the FDA User Fee Reauthorization Act of 2022 (FDAUFRA) was enacted, which included the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA). The current legislative authority for PDUFA VII expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years to fund the process for the review of prescription drug product applications.
Information related to FDA’s preparation for the seventh reauthorization of PDUFA will be hosted on this page as it becomes available.
PDUFA VIII Reauthorization Kickoff Public Meeting - July 14, 2025
The Food and Drug Administration is holding a public meeting on July 14, 2025 to kick off the process for reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032.
