FDA Releases Draft Industry Guidance On Developing New Antibacterial Drugs

The Food and Drug Administration July 1 released a draft guidance for industry intended to assist sponsors develop new antibacterial drugs, particularly in areas of unmet need, and new antibacterial drugs that are pathogen-focused.

The draft guidance, Antibacterial Therapies for Patients With Unmet Medical Need for the Treatment of Serious Bacterial Diseases, describes examples of approaches that may be used by sponsors as part of streamlined development programs. Some of these approaches are not new, but are included to provide examples of various ways of collecting the evidence needed to demonstrate safety and efficacy to address unmet medical needs, the ...