FDA-TRACK: ADUFA Animal Drug Applications and Supplements
Animal Drug Applications and Supplements
On August 14, 2018, the third reauthorization of the Animal Drug User Fee Act (ADUFA), referred to as ADUFA IV, was signed into law. ADUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing ADUFA for an additional five years (FY 2019 through FY 2023). ADUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal drug industry and provides FDA with resources to improve its review of applications for new animal drugs, with the result that safe and effective new products will be more readily available.
Download Animal Drug Applications and Supplements Dataset
Footnotes:
- * Performance is currently preliminary due to pending submissions.
- ^ Current fiscal year represents performance year-to-date (FY22 Q2).
- ADUFA III performance goals and commitments applicable FY 2014 - FY 2018.
- ADUFA IV 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.