Health Law Daily Wrap Up, VETERINARY DRUGS—FDA GUIDANCE NOTICES: FDA finalizes updated guidance on antimicrobial animal drug safety, (Aug 7, 2026)

By WK Editorial Staff

FDA issued final Guidance for Industry #152 updating its approach for evaluating the potential impact of antimicrobial new animal drugs on bacteria important to human health, incorporating scientific developments and stakeholder feedback since the guidance was first issued in 2003.

The Food and Drug Administration (FDA) announced the availability of final Guidance for Industry (GFI) #152, which describes the agency’s current approach for evaluating the potential microbiological effects of antimicrobial new animal drugs on bacteria of human health concern during the new animal drug approval process. The guidance updates a framework first issued in 2003 and revises FDA’s assessment of the importance of antimicrobial drugs used in human medicine, reflecting scientific developments and information that have emerged over the past two decades. FDA considered comments from industry, veterinarians, public health groups, and other stakeholders on a draft version of the guidance before finalizing the document. Among other changes, the final guidance provides additional detail on hazard characterization, clarifies the role of antimicrobial rankings in the risk assessment process, and explains FDA’s rationale for excluding topical antimicrobials from its rankings (Notice, 91 Fed. Reg. 50860 (Aug. 6, 2026)).

Dates. The announcement of the guidance is published in the Federal Register on August 6, 2026.

FederalRegisterIssuances: FDAGuidanceNotices FDCActNews SafetyNews VetNews