Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern (2003) is also known as?

• A. Guidance 152
• B. Guidance 149
• C. Guidance 140
• D. Guidance 160

Answer: (A)

This topic centers on a specific FDA CVM guidance that sets the framework for judging whether new antimicrobial drugs for animals might promote resistance in bacteria that matter for human health. In 2003, the guidance was published as Guidance for Industry 152, providing the recommended approach, data requirements, and interpretation needed to evaluate microbiological safety and resistance risk as part of the approval process. The other guidance numbers correspond to different topics and are not the document described here, so the correct reference is Guidance for Industry 152.