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  5. PDUFA VII: Fiscal Years 2023 – 2027
  1. Prescription Drug User Fee Amendments

PDUFA VII: Fiscal Years 2023 – 2027

In August 2017, the FDA Reauthorization Act of 2017 (FDARA) was enacted, which renewed the prescription drug user fee program (PDUFA) for a sixth time. The current legislative authority for PDUFA VI expires in September 2022.  At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years.

Information related to FDA’s preparation for the seventh reauthorization of PDUFA will be hosted here on this page as it becomes available.

PDUFA VII Commitment Letter

PDUFA VII Reauthorization Proposed Enhancements Public Meeting - September 28, 2021

The Food and Drug Administration (FDA or Agency) is announcing a virtual public meeting to discuss the proposed enhancements for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. Meeting Information

PDUFA VII Reauthorization Kickoff Public Meeting - July 23, 2020

The Food and Drug Administration held a virtual public meeting on July 23, 2020 to kick off the process for reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. Meeting Information

Industry Discussions on Reauthorization

Stakeholder Discussions on PDUFA VII Reauthorization

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