Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing Escherichia coli in Cattle; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (GFI #229) entitled "Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle." The purpose of this document is to provide recommendations to industry relating to study design and describe criteria the Center for Veterinary Medicine (CVM) thinks are the most appropriate for the evaluation of the effectiveness of new animal drugs that are intended to reduce pathogenic Shiga toxin-producing E. coli (STEC) in cattle.