FDA guidance on antimicrobials aims to prevent resistance

摘要

Agency outlines detailed approach to evaluating animal drugs' microbiologic effects on bacteria and human health. The Food and Drug Administration has released a guidance document that outlines a comprehensive, evidence-based approach for assessing the likelihood that an antimicrobial drug used to treat a food animal may cause an antimicrobial resistance problem in humans consuming meat and byproducts from that animal. The FDA issued the document to help drug sponsors understand the agency's process of evaluating whether a product proposed for approval can be used safely and effectively.