AGDUFA Performance Reports
On August 14, 2008, the Animal Generic Drug User Fee Act (AGDUFA) was signed into law. AGDUFA amends the Federal Food, Drug, and Cosmetic Act (FD&C Act) by authorizing the first generic animal drug user fee program for fiscal year (FY) 2009 through FY 2013. AGDUFA provides FDA with additional funds to help enhance the performance of the generic new animal drug review process. The authorization of AGDUFA also helps to enable FDA’s continued assurance that generic new animal drug products are safe and effective and consumers are provided a lower cost alternative to pioneer drugs.
In exchange for this authority, under AGDUFA, FDA agreed to pursue a comprehensive set of review performance goals and commitments to improve the timeliness and predictability of generic new animal drug reviews. These review performance goals help to expedite the review of abbreviated new animal drug applications (ANADAs) and reactivations, manufacturing supplemental ANADAs, and generic investigational new animal drug (JINAD) submissions. Additionally, FDA agreed to meet increasingly challenging review performance goals for these submissions over five years (FY 2009 through FY 2013). AGDUFA follows the Animal Drug User Fee Act (ADUFA) model and also is similar to the Prescription Drug User Fee Act (PDUFA) program. The expectation is that AGDUFA will bring predictability in review times for the animal drug industry and provide FDA with resources to improve its review of applications for generic new animal drugs, with the result that safe and effective new products will be more readily available.
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
Food and Drug Administration
10903 New Hampshire Avenue
Building 32, Room 4223
Silver Spring, Maryland 20903-0002