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The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.
On Feb. 7, 2018, FDA published guidance on the development, analysis, and presentation of microbiology data during the development of antibacterial drugs. The agency discusses the overall microbiology development program it says is needed to support clinical development and approval of antibacterial drugs administered systemically. The guidance also addresses microbiology data collected after drug approval.
The new guidance replaces Microbiology Data for Systemic Antibacterial Drugs-Development, Analysis, and Presentation, which was published in August 2016. FDA changed the presentation of microbiology data. This change was 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). This new section created new processes for susceptibility test interpretive criteria recognition. FDA is required to make changes, including establishing a web page for susceptibility test interpretive criteria and changes to the labeling for antibacterial and antifungal drugs on susceptibility test interpretive criteria.