FDA-TRACK: Animal Generic Drug User Fee Act Animal Drug Applications and Supplements

 

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Animal Generic Drug Applications and Supplements

• • Current Performance

• • Historical Performance

Relevant Links:

1. • AGDUFA IV Performance Goals and Procedures
2. • AGDUFA III Performance Goals and Procedures
3. • AGDUFA Performance Reports
4. • AGDUFA Report Information
5. • AGDUFA Meetings
6. • FDA-TRACK: CVM Dashboards

On September 30, 2023, the third reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), referred to as AGDUFA IV, was signed into law. AGDUFA IV amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing AGDUFA for an additional five years (FY 2024 through FY 2028). AGDUFA provides FDA with resources to enhance the performance and predictability of the generic new animal drug review process resulting in more readily available safe and effective new products.

Download AGDUFA Animal Generic Drug Applications and Supplements Dataset

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Footnotes:

1. * Performance is currently preliminary due to pending submissions.
2. ^ FY 2024 YTD includes preliminary performance as of 12/31/2023.
3. AGDUFA II performance goals and commitments applicable FY 2014 - FY 2018.
4. AGDUFA III performance goals and commitments applicable FY 2019 - FY 2023.
5. AGDUFA IV performance goals and commitments applicable FY 2024 - FY 2028.

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Note: The data provided on this website are produced on an ongoing basis for performance management purposes and are subject to change due to updates of preliminary estimates, corrections, or other reasons.