The FDA is announcing the release of a recently published Draft Guidance for Industry: Vaginal Microbicides: Development for the Prevention of HIV Infection
This draft guidance is intended to provide FDA's current thinking regarding development of vaginal microbicides for the prevention of human immunodeficiency virus (HIV) infection. Vaginal microbicides are products which may reduce HIV acquisition in women.
The guidance provides information about the types of nonclinical studies and clinical trials needed for vaginal microbicide development. The guidance focuses on drug development issues unique to vaginal microbicides including safety considerations and phase 3 trial considerations.
Also provided is information on approaches for developing combination microbicide products including drug-device combinations.
The guidance does not address other forms of HIV prevention such as oral pre-exposure prophylaxis agents, vaccines, or stand-alone physical barrier devices.
Sponsors are also encouraged to visit the FDA web site on Development of Vaginal Microbicides which provide 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.
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