|
|
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)
|
|
|
Documents in Portable Document Format (PDF) retain their original
format. To view or print these documents, you must use the Adobe
Acrobat Reader, which is free and available directly from
Adobe's Website with full installation instructions.
|
|
|