Issue Date: June 26, 2025
Issued by: Center for Drug Evaluation and Research,Office of New Drugs
Topic(s): Clinical – Antimicrobial
Status: Final
Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases – Questions and Answers: Guidance for Industry
Office of New Drugs The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases–Questions and Answers.” This guidance assists in the clinical development of new antibacterial drugs to treat serious bacterial diseases in patients with unmet medical needs, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking. This guidance finalizes the draft guidance entitled “Antibacterial Therapies for Patients With an Unmet Medical Need for the Treatment of Serious Bacterial Diseases–Questions and Answers (Revision 1)” issued on May 24, 2022.
Download the Guidance Document
