On August 14, 2018, the second reauthorization of the Animal Generic Drug User Fee Act (AGDUFA III) was signed into law. AGDUFA III amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by reauthorizing AGDUFA for an additional 5 years (FY 2019 through FY 2023). AGDUFA provides FDA with revenue to enhance the performance and predictability in review times for the animal generic drug industry and provide FDA with resources to improve its review that result in safe and effective new products will be more readily available. AGDUFA follows the Animal Drug User Fee Act (ADUFA) model and is also similar to the Prescription Drug User Fee Act (PDUFA) program. This ensures the timely and thorough review for abbreviated new animal drug applications (ANADAs) and generic investigational new animal drug (JINAD) submissions. AGDUFA enables FDA to ensure that generic new animal drug products are provided to consumers as a safe, lower cost alternative to pioneer drugs.
AGDUFA I, AGDUFA II and AGDUFA III
- AGDUFA I (FY 2009 to FY 2013) ADUFA I was signed into law on August 14, 2008. AGDUFA I established review performance goals for FDA, phased in over a 5-year period. The AGDUFA I performance goals lead to progressive, yearly performance improvements, with the on-time goal for review and action on submissions getting shorter each fiscal year. By the final year of AGDUFA I, FDA agreed to review and act on 90 percent of the submissions within the specified time
- AGDUFA II (FY 2014 to 2018) Under AGDUFA II (FY 2014 to 2018), FDA committed to a variety of process improvements to enhance and further improve the review process. This now includes the ability for industry to supply two-phased data submissions as part of the Chemistry Manufacturing and Controls (CMC) Technical Section. Also, industry can submit comparability protocols without substantial data in a JINAD file. The Agency is now developing and implementing a new, question-based review (QbR) process for bioequivalence submissions.
- AGDUFA III (FY 2019 to 2023). AGDUFA III includes a comprehensive set of FDA review performance goals and commitments designed to improve the timeliness and predictability of the review of abbreviated new animal drug applications (ANADAs) and reactivations, manufacturing supplemental ANADAs and reactivations, and generic investigational new animal drug (JINAD) submissions. AGDUFA III dramatically reduces review time goals across all submission types for the generic animal drug review program as well as converting to all electronic submissions.
Annual performance reports are prepared by the Office of Planning in collaboration with FDA’s Center for Veterinary Medicine (CVM).
For additional information on these reports, please contact:
Office of Planning, Evaluation and Risk Management
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002
AGDUFA Performance Reports
Performance reports for previous years are available in the FDA Archive.