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# FDA Guidance on Developing Bacterial Vaginosis Drugs
- URL: https://www.fdaweb.com/fda-guidance-on-developing-bacterial-vaginosis-drugs/
- Published: 2016-07-13T12:00:00.000Z
- Updated: 2026-09-14T21:14:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136167

FDA has posted a [draft guidance](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510948.pdf?ref=fdaweb.com) on “Bacterial Vaginosis: Developing Drugs for Treatment” that should assist sponsors in their overall clinical development program and clinical trial designs to support drugs for such indications. It focuses only on developing antibacterial drugs for treating symptomatic bacterial vaginosis (BV). “There are epidemiological associations between BV and other adverse health outcomes, such as sexually transmitted infections including human immunodeficiency virus, postoperative infections, preterm birth, and other gynecological infections,” the guidance says. Sponsors are also encouraged to discuss with the agency trial designs and drug development issues related to developing drugs to address epidemiogically associated adverse health outcomes.