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.
This guidance replaces the guidance for industry Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation issued in August 2016. Changes to this guidance compared to the August 2016 version include changes in the presentation of microbiology data as required by section 3044 of the 21st Century Cures Act, which added section 511A to the Federal Food, Drug, and Cosmetic Act (FD&C Act). Section 511A created new processes for susceptibility test interpretive criteria recognition, required FDA to establish a web page for susceptibility test interpretive criteria, and required changes to the labeling for antibacterial and antifungal drugs on susceptibility test interpretive criteria, among other changes. FDA’s recommendations on implementing section 511A are described in section III.C.7., Location of Microbiology Information, section III.C.8., Postmarketing Microbiology Information, and Appendix D.