> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Antibacterial Therapies Development Q&A Guidance
- URL: https://www.fdaweb.com/antibacterial-therapies-development-q-a-guidance/
- Published: 2025-06-26T12:00:00.000Z
- Updated: 2026-09-14T15:15:20.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159421

FDA has published a guidance, *Antibacterial Therapies for Patients with an Unmet Medical Need for the Treatment of Serious Bacterial Diseases—Questions and Answers*, to help sponsors in the clinical development of new antibacterial drugs to treat serious bacterial diseases, particularly those caused by antimicrobial drug-resistant organisms, in patients with unmet medical need. 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) says that for new antibacterial drugs that treat serious bacterial diseases with a potential to address an unmet medical need, a more flexible development program may be acceptable to facilitate development.

The guidance finalizes a 5/2022 draft.