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FDA recently published final Guidance for Industry / Vaginal Microbicides: Development for the Prevention of HIV Infection.
The guidance provides the FDA's current thinking for development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. The final guidance supersedes the 2012 draft guidance and incorporates the FDA’s responses to public comments submitted to the Agency.
The guidance addresses issues related to nonclinical development, early phases of clinical development, phase 3 trial considerations, and safety considerations in vaginal microbicide development, including safety considerations in adolescent and pregnant populations.
The guidance also outlines development of combination microbicide products including drug-device combinations as well as combination products including microbicides which are intended for multiple indications.
This guidance does not discuss development of other forms of HIV prevention such as oral pre-exposure prophylaxis agents, vaccines, or stand-alone physical barrier devices.
The major updates in the final guidance are to the clinical trial considerations and nonclinical pharmacology/toxicology sections.
Guidance for Industry / Vaginal Microbicides: Development for the Prevention of HIV Infection is available on the FDA web site.
Sponsors are also encouraged to visit the FDA.gov site on Development of Vaginal Microbicides which provides access to additional resources including select presentations and publications by FDA staff, links to other relevant FDA guidances, and information about interacting with the FDA in early microbicide development.
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration
Kimberly Struble
Division of Antiviral Products
Food and Drug Administration
Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration
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