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# Antibacterial Therapy Q&A Guidance
- URL: https://www.fdaweb.com/antibacterial-therapy-q-a-guidance/
- Published: 2022-05-24T12:00:00.000Z
- Updated: 2026-09-14T17:45:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151888

FDA has published a draft guidance, *Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers (Revision 1)*, to assist sponsors in developing new antibacterial drugs. Specifically, the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/antibacterial-therapies-patients-unmet-medical-need-treatment-serious-bacterial-diseases-questions?ref=fdaweb.com) explains the agency’s current thinking about possible development programs and clinical trial designs for antibacterial drugs to treat serious bacterial disease in patients with an unmet medical need, including patients with a serious bacterial disease for which effective antibacterial drugs are limited or lacking.

The draft revises an 8/2017 guidance. FDA says significant changes from the 2017 version include the possibility to conduct noninferiority trials that include subjects with infections caused by certain drug-resistant pathogens since effective active controls are now available. More detail also is provided for the currently used noninferiority trial designs that may be used with a wider noninferiority margin, including cases for which the trial population is enriched for subjects with infections caused by certain drug-resistant organisms.

The draft does not contain a discussion of the general issues of statistical analysis or clinical trial design.