Responsibilities of animal scientists and drug sponsors when conducting research with investigational new animal drugs.

The Center for Veterinary Medicine of the Food and Drug Administration (FDA) is charged with implementing the Federal Food, Drug and Cosmetic Act as it pertains to animal drugs and food additives. Title 21 of the Code of Federal Register Part 500 contains the regulations promogulated by the FDA as it implements this Act. Investigational New Animal Drug (INAD) applications provide for the shipment of experimental drugs and provide for the establishment of reconditioning procedures so edible products from research animals may be used for food. The record-keeping requirements for holders of INAD and for researchers are described. Protocol development and importation of investigational new animal drugs are discussed.