> ## 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.

# Bacterial Vaginosis Drug Development Guidance
- URL: https://www.fdaweb.com/bacterial-vaginosis-drug-development-guidance/
- Published: 2019-08-01T12:00:00.000Z
- Updated: 2026-09-15T01:41:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144667

FDA has issued a final guidance, *Bacterial Vaginosis: Developing Drugs for Treatment*, to assist sponsors in the overall development program and clinical trial designs to support development of topical and systemic drugs and biological products for treatment of bacterial vaginosis. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/bacterial-vaginosis-developing-drugs-treatment-guidance-industry?ref=fdaweb.com) focuses on considerations that are specific to bacterial vaginosis drug development. It does not contain discussion of the general issues of statistical analysis or clinical trial design.

Contents of the guidance are Introduction and Development Program (general considerations, specific efficacy trial considerations, and other considerations).