A
new FDA guidance document of interest has been issued. The title is
“Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis,
and Presentation Guidance for Industry.”
The
introduction runs: “The purpose of this guidance is to assist sponsors in the
development, analysis, and presentation of microbiology data during antibacterial
drug development. Specifically, this guidance addresses the Food and Drug
Administration’s (FDA’s) current thinking regarding the overall microbiology
development program needed to support clinical development and approval of antibacterial
drugs administered systemically as well as microbiology information collected
after approval.”
Posted by Dr. Tim Sandle
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Pharmaceutical Microbiology