User Fees

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 paid 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.

In 2013, reauthorization of the Animal Generic Drug User Fee Act of 2008 ("AGDUFA II") was approved by Congress. GADA played an instrumental role in representing the generic animal drug sponsors who are impacted by user fees, both in negotiating the terms of the reauthorization with FDA, and providing testimony to the U.S. Senate Committee on Health, Education, Labor and Pensions in support of the reauthorization.

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