Public Meeting on the Recommendations for PDUFA Reauthorization

The FDA is holding a hybrid public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA).
About this Event

Date: September 16, 2026

Time: 9:00 a.m. to 2:00 p.m.

In-Person Location: Great Room, FDA White Oak Campus (10903 New Hampshire Avenue, Silver Spring, MD, 20903). Enter at Building 1 to clear security.

Webinar Location: The webinar link will be emailed to registrants and will be posted on FDA's public webpage: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-recommendations-reauthorization-prescription-drug-user-fee-act-pdufa-09162026.

Description

The Food and Drug Administration (FDA) is hosting 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. PDUFA authorizes FDA to collect user fees to support the process for the review of human drug applications. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting prescription drug user fees in future fiscal years. Following discussions with the regulated industry and periodic consultations with public stakeholders, the Federal Food, Drug, and Cosmetic Act directs FDA to publish the recommendations for the reauthorized program in the Federal Register, hold a meeting at which the public may present its views on such recommendations, and provide for a period of 30 days for the public to provide written comments on such recommendations. FDA will then consider such public views and comments and revise such recommendations, as necessary.

FDA invites public comment as the Agency continues the process to reauthorize the program in FYs 2028—2032. The comment period will close on October 16, 2026.

There will be an opportunity for stakeholders to provide comments during an Open Public Comment session at the end of the meeting. Registrants will receive more information on how to provide comments prior to the meeting. The request form will also be available on FDA's website: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-recommendations-reauthorization-prescription-drug-user-fee-act-pdufa-09162026.

As they become available, additional information (e.g. the Federal Register notice, the meeting agenda) will be provided on FDA's website: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-recommendations-reauthorization-prescription-drug-user-fee-act-pdufa-09162026.