Scientific Publications by FDA Staff

Vet Clin North Am Food Anim Pract 2013 Mar;29(1):1-10

Regulatory considerations for the approval of analgesic drugs for cattle in the United States.

Smith ER, Modric S

Continuous life-cycle management of veterinary drugs by the Food and Drug Administration Center for Veterinary Medicine (CVM) ensures that safe and effective approved animal drugs are available for use in the United States. This article summarizes basic requirements for the approval of new animal drugs, with a specific focus on the approval of analgesic drugs for use in cattle. CVM encourages drug companies to use innovative approaches to demonstrate the effectiveness of analgesic drugs for cattle. There is an obvious need for continued research into the development of new animal drugs for the control of pain in cattle.