Saturday, 14 April 2018

Microbiology Data for Systemic Antibacterial Drugs

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.”

To view the document, see: FDA

Posted by Dr. Tim Sandle

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