Meeting | Mixed
Event Title
Public Meeting on the Reauthorization of Generic Drug User Fee Amendments (GDUFA)
September 17, 2026
- Date:
- September 17, 2026
- Time:
- 9:00 a.m. - 2:00 p.m. ET
On This Page
FDA is announcing a public meeting to discuss proposed recommendations for the reauthorization of the Generic Drug User Fee Amendments for fiscal years 2028 through 2032. The hybrid public meeting will be held on September 17, 2026, 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.
Registration
Register for the meeting here. Registration is free for both in person and virtual attendance. In person attendance is based on space availability, with priority given to early registrants. Early registration is recommended because seating is limited; therefore, FDA may limit the number of in-person participants from each organization.
Public Comment
If you wish to present during a public comment session, use this form to request to participate in the public comment session during the meeting by 11:59 p.m. ET on September 3, 2026. Individuals and organizations with common interests are urged to consolidate or coordinate their comments and request time jointly. FDA will determine the amount of time allotted to each commenter, decide the approximate time each comment is to begin, and select and notify participants by September 10, 2026. No commercial or promotional material will be permitted to be presented at the public meeting.