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GUIDANCE DOCUMENT

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

Final
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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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.