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

Issue Date: February 7, 2018
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final

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

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.

Download the Guidance Document

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