1. Home
  2. Drugs
  3. News & Events for Human Drugs
  4. Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA) - 09/16/2026
  1. News & Events for Human Drugs

Meeting | Mixed

Event Title
Public Meeting on the Recommendations for Reauthorization of the Prescription Drug User Fee Act (PDUFA)
September 16, 2026


Date:
September 16, 2026
Time:
9:00 a.m. - 2:00 p.m. ET

On September 16, 2026, the Food and Drug Administration (FDA) 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 public meeting was held at the FDA White Oak campus in Silver Spring, Maryland, with a virtual option. This webpage contains the meeting agenda and additional meeting materials as they become available. For more background information on the meeting and to submit a written comment to the public docket, please see the Federal Register notice with assigned docket FDA-2026-N-8163 issued on August 14, 2026. The public docket closes on October 16, 2026.

Meeting Recording


Event Materials

Title File Type/Size
Meeting Agenda pdf (99.92 KB)
Slides pdf (476.56 KB)
Meeting Transcript pdf (393.67 KB)
Back to Top