Animal Drug User Fee Act of 2003 [ADUFA] Law and Legal Definition

The Animal Drug User Fee Act of 2003 (ADUFA) is a U.S. federal statute signed into law by President George Bush that amends the Federal Food, Drug, and Cosmetic Act (FFDCA) and authorizes FDA (Food and Drug Administration) to collect fees for certain animal drug applications, and for the establishments, products and sponsors associated with these and previously approved animal drug applications, in support of the review of animal drugs. ADUFA gives the FDA the resources and incentives to expedite New Animal Drug Applications. These additional resources support FDA’s responsibilities under the FFDCA to ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption. It is modeled after the successful Prescription Drug User Fee Act.