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# Guidance on Developing Drugs for Bacterial Vaginosis
- URL: https://www.fdaweb.com/guidance-on-developing-drugs-for-bacterial-vaginosis/
- Published: 2016-07-14T12:00:00.000Z
- Updated: 2026-09-14T21:14:22.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5136190

*Federal Register* Notice: FDA is making available a draft guidance for industry entitled *Bacterial Vaginosis: Developing Drugs for Treatment*. Its purpose is to assist sponsors in the clinical development of drugs for treating bacterial vaginosis (BV). It helps define enrollment criteria for BV trials and recommends that such trials be superiority trials. The draft guidance reflects recent developments in scientific information that pertain to drugs being developed for treating BV, including the characterization of the primary efficacy endpoint. To download this guidance, click [here](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510948.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-07-14/pdf/2016-16636.pdf?ref=fdaweb.com)