Financial Transparency and Efficiency of PDUFA

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Date: June 23, 2026 Time: 1:00 p.m. – 2:30 p.m. ET Location:

Event Location

Attend In Person or Online
Virtual: via webcast
In Person: FDA White Oak Campus

10903 New Hampshire Avenue
Building 31, Room 1503
Silver Spring, MD 20993
United States

Register to Attend

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, Biosimilar User Fee Act, and Generic Drug User Fee Amendments”. 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.

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

Past Meeting Materials

• 2025 Materials
• 2024 Materials
• 2023 Materials
• 2022 Materials
• 2021 Materials

Registration

Please register to attend the event via Teams. If you need special accommodations, please indicate this during registration or contact the Business Management Services (BMS) team at OFBABusinessManagementServices@fda.hhs.gov by June 20, 2026, at 11:59 PM Eastern Time.

• Content current as of:

  04/16/2026

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