FDA Proposes Revisions to Guidance on Evaluating Safety of Antimicrobial Animal Drugs Based on Their Importance in Human Medicine

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FDA issued a draft update to 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.” The guidance is a tool for assessing the risk of antimicrobial resistance (AMR) in people, which could result from the use of a medically important antimicrobial drug in food-producing animals. The scope and purpose of updated GFI #152 remains the same as the initial version of the guidance issued in 2003, but better aligns with current science and clinical practices in human medicine.

Updates to the guidance include revisions to the risk assessment framework, updated ranking criteria for determining the degree of medical importance of antimicrobial drug classes, and a revised ranking of antimicrobial drug classes (in Appendix A) as critically important, highly important, or important based on the newly updated ranking criteria.

FDA is accepting comments on the draft guidance for 90 days.

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