AHI Statement on Guidance for Industry #152

(August 6, 2027) The Food and Drug Administration’s Center for Veterinary Medicine (CVM) today issued updated Guidance for Industry #152 which outlines the qualitative risk assessment companies should follow when seeking approval for antimicrobial products used in food producing animals.  The document updates previous guidance and revises the classification of antimicrobial compounds according to their importance in human medicine.

Responsible antibiotic use in food-producing animals is essential to protecting public health and supporting animal welfare. Disease threats are a constant challenge for veterinarians and food producers who work to keep animals healthy. They rely on targeted, appropriate use of these medicines to combat these disease threats.

The animal health industry is committed to reducing the need for these medicines and has invested in vaccines, diagnostics and other measures.  In 2019 the global animal health sector introduced a “Roadmap for Reducing the Need for Antibiotics” and committed to 25 measurable goals to achieve this objective.  A final report on the progress made on meeting those goals can be found here.