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GUIDANCE DOCUMENT

CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle October 2015

Final

This guidance is being distributed for comment purposes only.

CVM GFI #229 Evaluating the Effectiveness of New Animal Drugs for the Reduction of Pathogenic Shiga Toxin-Producing E. coli in Cattle

Docket Number:
FDA-2015-D-0235
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

This guidance provides recommendations to industry relating to study design and describes 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.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2015-D-0235.

Questions?

Contact Point
CVM
Center for Veterinary Medicine
Food and Drug Administration
7500 Standish Pl, HFV-1
Rockville, MD 20855
AskCVM@fda.hhs.gov
(240) 402-7002