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  1. FDA-TRACK: Agency-wide Program Performance

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

 

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FDA-TRACK: AGDUFA Performance
AGDUFA Performance Dashboard User Guide
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Animal Generic Drug Applications and Supplements

On August 14, 2018, the second reauthorization of the Animal Generic Drug User Fee Act (AGDUFA), referred to as AGDUFA III, was signed into law. ADUFA III amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing AGDUFA for an additional five years (FY 2019 through FY 2023). 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

Footnotes:

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

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

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