Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments September 30, 2025

Meeting | Mixed

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• Date: September 30, 2025
• Time: 9:30 a.m. - 10:40 a.m. ET
• Location: White Oak Campus: The Great Room; FDA Headquarters; 10903 New Hampshire Avenue; Bldg. 31, Great Room Conference Center; Silver Spring, MD 20993-0002; United States

Meeting Recording

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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:

• 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.

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. 

2025 Meeting Materials

• Agenda
• Meeting Transcript
• Meeting Recording

Past Meeting Materials

• 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

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Event Materials

Title	File Type/Size
Meeting Agenda	pdf (136.55 KB)
Meeting Transcript	pdf (154.08 KB)