THE USFWS AQUATIC ANIMAL DRUG APPROVAL PARTNERSHIP PROGRAM: WHAT WE DO AND HOW WE DO IT

The U.S. Fish and Wildlife Service's (USFWS) Aquatic Animal Drug Approval Partnership Program (AADAP) is the only program in the United States that is exclusively dedicated to acquiring U.S. Food and Drug Administration (FDA) approval of new medications for use in fish culture and fisheries management.  To gain FDA approval of a drug, sufficient data must be generated and accepted by the FDA's Center for Veterinary Medicine (CVM) to demonstrate the drug is safe for humans, target animals, and the environment, and can be manufactured consistently and is effective for its proposed use(s).  To fulfill this mission, the AADAP team collaborates with federal, state, tribal, academic, and private sector partners to implement the national Investigational New Animal Drug (INAD) program, conduct research to support New Animal Drug Approvals (NADAs), and disseminate aquatic animal drug use information via a professional outreach program.  This presentation will serve as an overview of the aquatic animal drug approval process as well as an update of the current status of FDA-approved drugs and those which are currently available under INAD exemptions.  In addition, this presentation will allow the AADAP team to inform the audience on the current needs for various pivotal studies.