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FDA Issues Guidance to Evaluate Effectiveness of New Animal Drugs for STEC Reduction in Cattle

Wednesday, October 21, 2015

(North American Meat Institute)

The Food and Drug Administration (FDA) announced the availability of a guidance document entitled "Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli (STEC) in Cattle." The document's purpose is to provide recommendations to industry relating to study design and to describe criteria the Center for Veterinary Medicine considers most appropriate for evaluating the effectiveness of new animal drugs that are intended to reduce pathogenic Shiga toxin-producing E. coli in cattle. Public comments regarding the guidance may be submitted at any time either online or by mail to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, Maryland 20852.

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