The Animal Generic Drug User Fee Act of 2008 (AGDUFA) was signed into law on August 14, 2008 (Pub. L. 110-316). Under AGDUFA, generic drug product sponsors for the first time will pay user fees to provide essential resources to FDA’s Center for Veterinary Medicine (CVM) to improve the generic animal drug application review process leading to a shorter regulatory review cycle—getting high quality, affordable generics to veterinarians, and animal and pet owners, faster.
Related Resources
FDA Announces FY 2011 Generic Drug User Fees
Federal Register Notice with 2009 Generic Drug User Fees
FDA Announces Authorization to Collect AGDUFA Fees, March 16, 2009
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