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 Public Meeting July 23, 2020
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2023 through 2027. Meeting Information
Industry Discussions on Reauthorization
- October 7th, 2020: Finance Subgroup (PDF - 158 KB)
- September 30th, 2020: Finance Subgroup (PDF - 146 KB)
- September 30th, 2020: Pre-Market (PDF - 146 KB)
- September 30th, 2020: Digital Health and Informatics Subgroup (PDF - 112 KB)
- September 29th, 2020: Regulatory Decison Tools Subgroup (PDF - 158 KB)
- September 29th, 2020: CBER Breakout (PDF - 124.22 KB)
- September 29th, 2020: Steering Committee (PDF - 155 KB)
- September 22nd, 2020: Steering Committee (PDF - 163 KB)
- September 15th, 2020: Steering Committee (PDF - 150 KB)
Stakeholder Discussions on PDUFA VII Reauthorization
- September 25, 2020 (PDF - 215 KB)