FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary
FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary
START - SUBSCRIBE BOX Dec 30 2021
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MENU ACCORDION STARTS Dec 30 2021
END - SUBSCRIBE BOX Dec 30 2021
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Biosimilar Applications and Supplements
Procedural Notifications
Procedural Responses
Meeting Management
- • Current Performance
- • Historical Performance
- • Goals Summary
- • Current Performance
- • Historical Performance
- • Goals Summary
- • Current Performance
- • Historical Performance
- • Goals Summary
- • Current Performance
- • Historical Performance
- • Goals Summary
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Relevant Links:
- • BsUFA III Commitment Letter
- • Biosimilar User Fee Amendments
- • Biosimilar Definitions
- • BsUFA Reauthorization Act
- • FDA-TRACK: BsUFA Performance Reports
- • FDA-TRACK: CDER Biosimilars Dashboard
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The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.
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MENU ACCORDION ENDS Dec 30 2021
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Summary
FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary