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# Guide in Antibacterial Drug Microbiology Data
- URL: https://www.fdaweb.com/guide-in-antibacterial-drug-microbiology-data/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140710

FDA has issued a [guidance](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM182288.pdf?ref=fdaweb.com) on “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation.” The document provides agency recommendations on 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. It replaces the guidance entitled “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation” issued 8/2016.