Opportunity
Federal Register #FDA-1998-D-0038
FDA Guidance on Evaluating Antimicrobial New Animal Drugs for Microbiological Safety
Buyer
Food and Drug Administration
Posted
August 06, 2026
Identifier
FDA-1998-D-0038
The Food and Drug Administration (FDA), under the Department of Health and Human Services, has issued final guidance for industry regarding the evaluation of antimicrobial new animal drugs for microbiological safety. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - Purpose: - Release of final guidance (GFI #152) for evaluating the safety of antimicrobial new animal drugs with respect to their microbiological effects on bacteria of human health concern - Key Details: - Outlines FDA's methodology for qualitative risk assessment of antimicrobial drugs - Ranks antimicrobial drugs based on their importance to human medicine - No products, OEMs, or vendors are being requested or procured - Guidance is intended to inform industry and stakeholders about FDA's evaluation process - Unique Requirements: - Focus on microbiological safety and risk assessment methodology for new animal drug applications - Addresses concerns related to antimicrobial resistance and human health - No procurement activity, product requests, or service requirements are included in this notice
Description
The Food and Drug Administration (FDA) has announced the availability of final guidance for industry (GFI) #152 titled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern." This guidance outlines FDA's current method for evaluating potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern as part of the new animal drug application process. The guidance includes a qualitative risk assessment methodology and ranks antimicrobial drugs according to their importance to human medicine. It aims to ensure the microbiological safety of antimicrobial drugs used in animals, addressing concerns related to bacteria of human health concern.