Meeting | Mixed
Event Title
Public Meeting on the Reauthorization of the Prescription Drug User Fee Act (PDUFA)
July 14, 2025
- Date:
- July 14, 2025
- Time:
- 9:00 a.m. - 2:00 p.m. ET
On July 14, 2025, the Food and Drug Administration (FDA or Agency) held a public meeting to discuss proposed recommendations for the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. The meeting agenda and additional materials will be posted to this website as they become available.
For more background information on the meeting or to submit comments, please see the Federal Register notice with assigned docket FDA-2025-N-0816 issued on May 19, 2025. The public docket closes on August 14, 2025.
FDA also published a Federal Register notice with assigned docket FDA-2025-N-0834 to request that public stakeholders notify FDA of their intent to participate in periodic consultation meetings on the reauthorization of PDUFA. Requests must be submitted by August 4, 2025.