Animal user fees

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20
Oct

Animal Drug User Fees for FY 2024 Just Howled Out Today!

By    Oct 20, 2023    Animal Drugs Animal generic drug user fees Animal user fees Regulatory Affairs

On September 30, 2023, the Animal Drug and Animal Generic Drug User Fee Amendments of 2023 were signed into law as part of H.R. 5860.  The amendments reauthorize the Animal Drug User Fee Act (ADUFA) and the Animal Generic Drug User Fee Act (AGDUFA) programs administered by the U.S. Food and Drug Administration until 2028. But not […]

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27
Jul

FDA Announces FY 2022 ADUFA Fees

By    Jul 27, 2021    Animal user fees FDA Regulatory Affairs

In a Federal Register Notice today (here), the Agency announced the FY 2022 user fees for New Animal Drug Applications.  While the application and certain fee-paying supplemental applications increased modestly, the remainder of the annual fees decreased.  “Fees for applications, establishments, products, and sponsors are to be established each year by FDA so that the […]

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