Microbicide product developmentMaguire, RobinCurrent Opinion in HIV & AIDS: September 2008 - Volume 3 - Issue 5 - p 554–557 doi: 10.1097/COH.0b013e32830891e2 Microbicides: Edited by John Kaldor and Melissa Robbiani Abstract Author Information Purpose of review: The purpose of this overview is to summarize the essential parameters needed to establish a sound microbicide development strategy. Recent findings: In recent years more comprehensive regulatory guidelines that are applicable to microbicides have been developed. Additionally, the US Food and Drug Administration have begun providing specific guidance for microbicide development. Summary: Microbicide product development has been aided in recent years by new regulatory guidance that helps to establish a stepwise development strategy. Developing comprehensive profiles for three key criteria – quality, safety and efficacy – are essential for preparation of an investigational new drug application that will allow proceeding into clinical development to establish microbicide proof-of-concept. Population Council, New York, New York, USA Correspondence to Robin Maguire, Population Council, 1230 York Avenue, New York, NY, 10065, USA Tel: +1 212 327 8729; fax: +1 212 327 7981; e-mail: firstname.lastname@example.org © 2008 Lippincott Williams & Wilkins, Inc.