
FDA Publishes Antibacterial Drug Development Guidance
The guidance assists in the development, analysis, and presentation of microbiology data during antibacterial drug development.
FDA published
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.
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