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GUIDANCE DOCUMENT

Microbiological Data for Systemic Antibacterial Drug Products — Development, Analysis, and Presentation February 2018

Final
Docket Number:
FDA-2009-D-0408
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

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.


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All written comments should be identified with this document's docket number: FDA-2009-D-0408.