Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments June 23, 2026

Meeting | Mixed

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• Date: June 23, 2026
• Time: 1:00 p.m. - 2:30 p.m. ET
• 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:

• PDUFA VII program
• BsUFA III program
• GDUFA III program

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
  • Agenda
  • Meeting Transcript
  • Recording / Transcript
• 2024 Materials
  • Agenda
  • Presentation
  • Recording / Transcript
• 2023 Materials
  • Agenda
  • Presentation
  • Recording/Transcript
• 2022 Materials
  • Agenda
  • Presentation
  • Meeting Recording
  • Audio Transcript
• 2021 Materials
  • 2021 Agenda
  • 2021 Presentation
  • 2021 Webcast Recording - Passcode: &7UNVA%8
  • 2021 Transcript

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.

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Event Materials

Title	File Type/Size
Meeting Agenda | Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments | 06/23/2026	pdf (136.73 KB)