The market for animal drugs is viable and lucrative, yet little information on the regulatory processes for them is readily available. This paper provides a review of the regulatory process for animal drugs, directed toward the pharmaceutical professional who understands the regulatory approval process of human drugs but has little exposure to the approval process for animal drugs. Comparisons will be made between the human and animal drug approval process.
Center for Veterinary Medicine.CVM 11/01/92 How 2nd Generation and the Drug Listing Act of 1972 Affects Medicated Feed Manufacturers. DHHS Pub. No (FDA) 92–6003, p 1. See 21CFR558.3. Revised November 1992.
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Federal Food, Drug, and Cosmetic Act, Section 503(f) 21 USCA § 353 (f)(c)(4) (1997).
