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GUIDANCE DOCUMENT

Vaginal Microbicides:Development for the Prevention of HIV Infection PDF November 2014

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2012-D-1120
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance provides recommendations for the development of vaginal microbicides regulated within the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) for the prevention of human immunodeficiency virus (HIV) infection. Specifically, this guidance addresses the FDA’s current thinking regarding the overall development program and clinical trial designs to support the development of vaginal microbicide drug products.

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