PDUFA VII: Fiscal Years 2023 – 2027

On September 30, 2022, the President signed into law the FDA User Fee Reauthorization Act of 2022. This new law includes the sixth reauthorization of the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary resources to maintain a predictable and efficient review process for human drug and biologic products.

FDA developed the proposed enhancements for PDUFA VII in consultation with drug industry representatives, patient and consumer advocates, health care professionals, and other public stakeholders from September 2020 through February 2021. FDA transmitted these proposed enhancements to Congress in January 2022, which are referred to in Title 1 of the FDA User Fee Reauthorization Act.

The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2023-2027 that will allow the agency to fulfill its mission to protect and promote public health by helping to bring to market critical new medicines for patients. This page contains the relevant information related to PDUFA VII and FDA’s implementation of the PDUFA VII enhancements. It also includes information related to the negotiations and consultations prior to the agreement.

Implementation

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