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  4. 2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments - 06/06/2024
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Meeting | Virtual

Event Title
2024 Financial Transparency and Efficiency of the Prescription Drug User Fee Act, Biosimilar User Fee Act, and Generic Drug User Fee Amendments
June 6, 2024


Date:
June 6, 2024
Time:
9:30 AM - 10:40 AM ET

Description

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.

This year’s public meeting will take place remotely on June 6, 2024, from 9:30 AM to 10:40 AM Eastern Time.

Docket No. FDA-2019-N-1875

View the Federal Register Notice announcing the meeting.

2024 Meeting Materials


Past Meeting Materials

2023 Materials

2022 Materials

2021 Materials


 
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