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August 6, 2026
The U.S. Food and Drug Administration today issued the final version of Guidance for Industry (GFI) #152, Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to their Microbiological Effects on Bacteria of Human Health Concern.
Antimicrobial resistance (AMR) occurs when bacteria evolve to survive exposure to drugs designed to kill them, making infections harder to treat. Because some of the same classes of antimicrobials used in animals are also important to treating human infections, the FDA evaluates the potential AMR risk to people when reviewing new animal drug applications for antimicrobial drugs.
GFI #152 outlines a qualitative risk assessment framework for the FDA to evaluate whether and to what degree a given antimicrobial drug used in food-producing animals could pose a risk to human health through the food supply. It also includes Appendix A, which ranks antimicrobial drugs by their relative importance to human medicine, placing each into one of three categories: critically important, highly important, or important. These rankings help inform the risk assessment but are not intended to serve as a standalone risk management tool.
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