U.S. Department of Health and Human Services Office of Disease Prevention and Health Promotion

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
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Objectives related to this resource (2)

Prevent an increase in the proportion of nontyphoidal Salmonella infections that are resistant to multiple drug classes — FS‑05
Baseline only
Prevent an increase in the proportion of macrolide antibiotic-resistant Campylobacter infections — FS‑06
Baseline only

Suggested Citation

1.

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 https://www.fda.gov/regulatory-information/search-fda-guidance-documents/antibacterial-therapies-patients-unmet-medical-need-treatment-serious-bacterial-diseases