Ensuring safe and effective use of veterinary medicines falls under the supervision of the FDA’s Center for Veterinary Medicine (CVM). There are three different categories of products: 1) animal drugs; 2) animal feed (which includes pet food); and 3) veterinary devices.
There are three different types of New Animal Drug applications, requiring regulatory approval by FDA: 1) New Animal Drug Application (NADA); 2) Approved New Animal Drug Application (ANADA); and 3) Conditional New Animal Drug Application (CNADA). On the other hand, pet food/animal feed do not require pre-market approval by FDA. However, like human food, they are required to be pure and wholesome, contain no harmful or deleterious substances, and be truthfully labeled, as outlined under the Federal Food, Drug, and Cosmetic Act.
NHP Consulting will guide you through the classification process and submit the required regulatory documentation to achieve compliance.