ABSTRACT
This chapter outlines the steps required to bring the veterinary products to market in the United States. It discusses the components of the initial filing of an Investigational New Animal Drug Application and the organization and contents of the New Animal Drug Application. From a regulatory perspective, veterinary animal health products are divided into two groups: those given to companion animals and those administered to food-producing animals. Regulations governing veterinary products, as well as the organization of the Food and Drug Administration's Center for Veterinary Medicine (CVM) are presented. To initiate clinical field studies with a new animal drug, the drug must first be listed with the CVM as an Investigational New Animal Drug. Effectiveness and target animal safety evaluation are the responsibility of divisions, which evaluate drugs for therapeutic use in both food animals, non-food animals. The major risk assessment effort connected with products for food-producing animals is the determination of the safe concentration of drug residues in edible tissues.
