Registration

Registration for the FDA Financial Public Meeting has closed, but you can still join via livestream on Tuesday, September 30 at 9:30 AM ET. This meeting will cover updates on financial transparency and efficiency regarding the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA). Seating is limited for registered personnel in the Great Room.

The Food and Drug Administration (FDA or the Agency) is announcing its annual public meeting and opportunity for public comment on “Financial Transparency and Efficiency of the Prescription Drug User Fee Act (PDUFA), Biosimilar User Fee Act (BsUFA), and Generic Drug User Fee Amendments (GDUFA)”. This public meeting is intended to meet performance commitments included in PDUFA VII, BsUFA III, and GDUFA III. These user fee programs were reauthorized as part of the FDA User Fee Reauthorization Act of 2022 signed by the President on September 30, 2022. The complete set of performance goals for each program are available at:

This meeting will provide FDA the opportunity to update interested public stakeholders on topics related to the financial management of PDUFA VII, BsUFA III, and GDUFA III. This year, FDA will present the 5-year financial plans for each of these programs and update participants on the progress towards implementing resource capacity planning as part of fee setting and modernized time reporting.

This year’s public meeting will take place at the FDA White Oak Campus in the Great Room, in Section A, and online via Microsoft Teams on September 30, 2025, from 9:30 AM to 10:40 AM Eastern Time.

Docket No. FDA-2019-N-1875

The Federal Register Notice announcing the meeting can be found here.