处方药用户收费法案、生物类似药用户收费法案及仿制药用户收费修正案的财务透明度和效率 – 2026年6月23日
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News & Events for Human Drugs Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments – 06/23/2026 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. 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. 2025 MaterialsAgendaMeeting TranscriptRecording / Transcript 2024 MaterialsAgendaPresentationRecording / Transcript 2023 MaterialsAgendaPresentationRecording/Transcript 2022 MaterialsAgendaPresentationMeeting RecordingAudio Transcript 2021 Materials2021 Agenda2021 Presentation2021 Webcast Recording – Passcode: &7UNVA%82021 Transcript 2021 Webcast Recording – Passcode: &7UNVA%8 10903 New Hampshire Avenue Building 31, Room 1503 Silver Spring, MD 20993 United States
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