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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

The Food and Drug Administration is announcing 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 will be held at the FDA White Oak campus in Silver Spring, Maryland, with a virtual option. The meeting agenda and additional materials will be posted to this website 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.

Meeting Registration

FDA recommends registering to attend the meeting and receive relevant communications on Eventbrite, though registration is optional and not required.

Public Comment Opportunity

If you are interested in making a verbal statement during the public comment session at the meeting, please submit a request by September 2, 2026, 11:59 p.m. Eastern Time. FDA will select and notify participants by September 9, 2026.


Event Materials

Title File Type/Size
Draft Meeting Agenda pdf (78.99 KB)
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