The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #152 entitled "Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern." This guidance document informs interested parties about 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.
US Federal Register - FDA Guidance Notices · August 06, 2026
Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry
Original title: Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to their Microbiological Effects on Bacteria of Human Health Concern; Guidance for Industry; Availability
FDA guidance on evaluating microbiological effects of antimicrobial new animal drugs on human-health-concern bacteria in new animal drug applications.
Published by US Federal Register - FDA Guidance Notices. HealthSignal links to the original document; the summary above is extracted from the source text.