ABSTRACT

The Food and Drug Administration (FDA) Center for Veterinary Medicine (CVM) approves new animal drug if the sponsor demonstrates that there is substantial evidence of effectiveness to support the intended use of a veterinary drug product. The sponsor must also show that the drug product is safe for use in the target animal species, safe to the environment, and that unsafe drug residues will not be present in meat, milk, or eggs used as food for people or other animals. This entry briefly summarizes some of the fundamental attributes associated with animal drug product development, and then moves to a more detailed overview of updates, current challenges, and new initiatives within the field.