The purpose of this guidance is to assist sponsors in the development, analysis, and presentation of microbiology data during antibacterial drug development.
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 the previous one, which was published in August 2016. FDA changed the presentation of microbiology data and added section 511A. 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.