Animal Generic Drug User Fees

The Act

The Animal Generic Drug User Fee Act of 2008 (AGDUFA), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and authorized FDA to collect fees to support the review of generic new animal drugs. These additional resources support FDA's responsibilities under the Act to ensure that generic new animal drug products are safe and effective for animals as well as human consumers with respect to animals intended for food consumption.

This program is similar to the very successful programs for pioneer new animal drugs, the Animal Drug User Fee Act, and human drugs and medical devices, the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act.

Complete Text of the Law

Performance Goals

Fees

Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2009(Federal Register, Sept. 15, 2008)
PDF (52 KB)

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