The U.S. Food and Drug Administration has published guidance on study design and criteria that 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 Escherichia coli (STEC) in cattle.

Section II discusses general considerations regarding the development of protocols, study conduct, animal welfare, substantial evidence of effectiveness, experimental parameters, nutritional content of experimental diets, and the assessment of drug concentrations in experimental diets. Section III discusses the studies and analyses CVM recommends for sponsors to substantiate the effectiveness of pathogenic STEC reduction drugs.

The guidance is not a comprehensive source of information on conducting clinical effectiveness studies. Alternative study designs for providing substantial evidence of effectiveness may be acceptable. Sponsors should contact CVM to discuss their development plan prior to initiating any studies. Sponsors and clinical investigators should consult the Code of Federal Regulations (21 CFR Parts 511 and 514) for information on the proper shipment, use, and disposition of investigational new animal drugs, as well as submission of the results of clinical investigations. This guidance does not address the evaluation of human food safety with respect to microbial food safety and/or concerns related to antimicrobial resistance. CVM encourages sponsors to discuss any related concerns in their project plan with CVM as early as possible in the development process.

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency’s guidances means that something is suggested or recommended, but not required.