FDA prescription-drug user-fee comments close October 16
FDA’s public docket for proposed PDUFA reauthorization recommendations closes October 16.
What the record says
FDA held a September 16 meeting about proposed recommendations for Prescription Drug User Fee Act reauthorization for fiscal years 2028–2032. Its page provides the recording and meeting materials and directs written comments to the public docket.
Source details and supporting locations.
Practical next step
Use the official FDA page and docket FDA-2026-N-8163 to check submission instructions before the October 16 deadline.
Limits and what is not established
The meeting has already occurred. This is a comment opportunity on proposed recommendations, not proof that reauthorization or new fees have been enacted.
Sources checked October 15, 2026. Later notices may change instructions or arrangements.
Original sources
U.S. Food and Drug Administration: original information