FDA Publishes 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 The final guidance supersedes the 2012 draft guidance and incorporates the FDA’s responses to public comments submitted to the Agency.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."   For more information, read the FDA press release or view the guidance.