> ## 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 Q&A Guidance
- URL: https://www.fdaweb.com/antibacterial-therapies-q-a-guidance/
- Published: 2025-07-29T12:00:00.000Z
- Updated: 2026-09-14T15:17:43.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159589

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 assist 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](http://www.fdaweb.com/download.php?file=opq%5Fwhitepaper%5Fqualitymgmtinitiatives%5F250728.pdf) says sponsors are encouraged to discuss proposed approaches with the agency.

The guidance finalizes a 5/2022 draft guidance.