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The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.
FDA published guidance on Aug. 25, 2016 regarding microbiology data in antibacterial drug development. The guidance addresses FDA’s recommendations for a microbiology development program to support development and approval of antibacterial drugs and the collection of postapproval information.
The guidance outlines a microbiology development program. It specifically addresses early development nonclinical considerations, including antibacterial spectrum of activity, mechanism of action, intracellular antimicrobial concentration assessment, and resistance studies. In-vitro antimicrobial susceptibility test methods used during drug development are also discussed. The guidance also addresses first and second lists of target bacteria in labeling, antibacterial interactions and fixed combination studies, animal models of infection, microbial information collected in clinical trials, and electronic submissions.