AADAP Summary...

The AADAP Program was officially established within the Service’s National Fish Hatchery System in January 2003 with the strong support of then Service Director Steve Williams. The stated goal of AADAP is to ensure continued progress towards obtaining FDA-approved and EPA-compliant new animal drugs for use in Federal, State, Tribal and private aquaculture programs throughout the United States. As its name implies, the AADAP is a broad, partner-based program of national scope. Utilizing increased program funding and staff, the AADAP incorporates ongoing Service compassionate Investigational New Animal Drug (INAD) exemption and New Animal Drug Application (NADA) activities that were previously coordinated by the Service’s National INAD Office (NIO). Ongoing and expanded activities include INAD administration, the National INAD Program that allows for participation by non-Service facilities on Service-held INADs, and a drug research program that is focused on the generation of efficacy and target animal safety data to NADAs. Added responsibilities of AADAP include a defined role in NADA management and information transfer and dissemination. Although the NIO remains in existence, it is now a part of the AADAP Program, both of which are located in Bozeman, Montana USA. In somewhat generic terms, the AADAP will help to lead a coordinated national effort to generate data, analyze results, compile final study reports, disseminate information and data, and manage all other aspects of requisite data submissions to FDA in support of new animal drug approvals for aquatic species. The AADAP builds on long-standing partnerships between the Service’s NIO and over 50 Federal, State, Tribal and/or private agencies or organizations. The AADAP, in its role of obtaining new approved drugs and chemicals for aquatic species, is integral to the Service’s successful stewardship of our natural resources for the enjoyment of all Americans.

Complete AADAP History and Summary

Functional Evolution of NIO to AADAP (past, current, and future)

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LAST UPDATED: 16-Jan-2013