CVM GFI #152 Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern January 2023

GUIDANCE DOCUMENT

• Docket Number: FDA-1998-D-0038
• Issued by: Center for Veterinary Medicine

Prior to approving an antimicrobial new animal drug application, FDA must determine that the drug is safe and effective for its intended use in the animal. The Agency must also determine that the antimicrobial new animal drug intended for use in food-producing animals is safe with regard to human health (21 CFR 514.1(b)(8)). FDA considers an antimicrobial new animal drug to be “safe” if it concludes that there is reasonable certainty of no harm to human health from the proposed use of the drug in food-producing animals. This document provides guidance for industry to evaluate potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process.

This guidance document outlines a risk assessment approach to evaluate the microbial food safety risks posed by antimicrobial new animal drugs. Within the context of risk assessment, many possible mechanisms to address the development of antimicrobial resistance resulting from the use of antimicrobial new animal drugs in food-producing animals are available to the sponsor. Alternative processes that may be more appropriate to a sponsor’s drug and its intended conditions of use may be used to characterize the microbial food safety of that drug.

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All written comments should be identified with this document's docket number: FDA-1998-D-0038.

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