FDA-TRACK: Animal Generic Drug User Fee Act Review Goals Summary

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Animal Generic Drug Applications and Supplements

• • Current Performance

• • Historical Performance

• • Goals Summary

Relevant Links:

1. • AGDUFA IV Performance Goals and Procedures
2. • AGDUFA Performance Reports
3. • AGDUFA Report Information
4. • AGDUFA Meetings
5. • 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.

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