Public Meeting on the Reauthorization of GDUFA

Date: July 11, 2025

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:

Description

The Food and Drug Administration (FDA or Agency) is announcing a hybrid public meeting on the reauthorization of the Prescription Drug User Fee Act (PDUFA) for fiscal years (FYs) 2028 through 2032. PDUFA authorizes FDA to collect user fees for the process for the review of human drugs. The current legislative authority for PDUFA expires in September 2027. At that time, new legislation will be required for FDA to continue collecting user fees in future fiscal years. The Federal Food, Drug, and Cosmetic Act (FD&C Act) requires that FDA begin the PDUFA reauthorization process by publishing a notice in the Federal Register requesting public input and holding a public meeting where the public may present its views on the reauthorization. FDA invites public comment as the Agency begins the process to reauthorize the program in FYs 2028—2032. The comment period will close on August 11.

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.

As they become available, additional information (e.g. the Federal Register notice, the meeting agenda) will be provided at this link: https://www.fda.gov/drugs/news-events-human-drugs/public-meeting-reauthorization-generic-drug-user-fee-amendments-gdufa-06272025