Issue Date: November 19, 2014
Issued by: Center for Drug Evaluation and Research
Topic(s): Clinical – Antimicrobial
Status: Final
Vaginal Microbicides:Development for the Prevention of HIV Infection PDF
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.
Download the Guidance Document
