title: Regulatory framework for the availability and use of animal drugs in the United States.
abstract: The goal of this article is to help practitioners understand the regulatory framework and basis for the approval of new animal drugs, the terminology and specific meaning of terms related to drug approval, and the marketing and use of veterinary drugs in companion animal practice. Understanding the differences between approved versus unapproved drugs and their use helps practitioners make the appropriate clinical decisions on their patients' treatment. Only when buying approved animal drugs can clinicians be assured of product safety, effectiveness, and manufacturing to the strict standards for quality, purity, and potency, as well as truthful and complete labeling.
authors.affiliation: Office of New Animal Drug Evaluation, Center for Veterinary Medicine, Rockville, MD 20855, USA. sanja.modric@fda.hhs.gov
authors.forename: Sanja
authors.initials: S
authors.lastname: Modric
mesh_terms: D000818:Animals; D017277:Drug Approval; D007880:Legislation, Drug; D011358:Product Surveillance, Postmarketing; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence*; D019155:Veterinary Drugs
chemical_list: D019155:Veterinary Drugs
keywords: Approved versus unapproved drugs; Drug approval process; Regulatory; Safety