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. 2013 Sep;43(5):1005-12.
doi: 10.1016/j.cvsm.2013.04.001. Epub 2013 Jun 5.

Regulatory framework for the availability and use of animal drugs in the United States

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Regulatory framework for the availability and use of animal drugs in the United States

Sanja Modric. Vet Clin North Am Small Anim Pract. 2013 Sep.

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.

Keywords: Approved versus unapproved drugs; Drug approval process; Regulatory; Safety.

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