- Date:
- July 11, 2025
- Time:
- 9:00 a.m. - 2:00 p.m. ET
The Food and Drug Administration (FDA or Agency) is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments (GDUFA) for fiscal years (FYs) 2028 through 2032. The hybrid public meeting will be held on July 11, 2025, from 9 a.m. to 2 p.m. ET. The meeting agenda, public docket information, additional materials, and any other updates will also be posted to this website as they become available. For more background information on the meeting or to submit comments, please see the Federal Register notice with assigned docket FDA-2025-N-0873 issued on May 19, 2025.
You can register for the meeting here. If you wish to present during a public comment session, please register by 11:59 p.m. ET on June 16, 2025 to receive a notification about an opportunity to participate in public comment.
