Guidance Document: Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases

About this resource:

HHS Non-systematic Review

Source: Food and Drug Administration, 2017

Last Reviewed: August 2018

Workgroups: Food Safety Workgroup

This webpage gives an overview of guidance on clinical development of new antibacterial drugs. Specifically, the guidance is for sponsors who are developing new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs. It also includes links to:

  • The federal register notice
  • Full guidance document
  • Public comments on the guidance
Read more about this resource

Objectives related to this resource (2)

Suggested Citation


U.S. Food and Drug Administration. (2017). Antibacterial therapies for patients with an unmet medical need for the treatment of serious bacterial diseases. Retrieved from