FDA Publishes Guidance on Microbiology Data for Antibacterial Drugs

Sponsors of systemic antibacterial drugs should evaluate their products against test panels of relevant bacteria and against approved drugs with similar mechanisms of activity, the FDA said, in a newly revised guidance.

For nonclinical spectrum of activity studies, sponsors should test in parallel FDA-approved antibacterials — ideally those with the same mechanism of action. If the candidate has a new mechanism of action, the FDA recommends including FDA-approved drugs with a similar spectrum of activity. If no such drug exists, sponsors should discuss what approved drugs to use.

In addition to evaluating the investigational drug’s mechanism of action, sponsors should provide information about the drug’s chemical similarities to existing antibacterial drugs and compare its activity profile to that of approved antibacterials with the same mechanism of action, the agency said.