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) |