Document Type

Report

Publication Date

2011

Abstract

The report summarizes a half-day meeting convened by the Population Council to clarify the wide variety of nomenclature and concepts associated with multipurpose prevention technologies (MPTs). The first section outlines where different types of products are reviewed within the FDA and existing processes that could be applied to MPTs. This is followed by a section that reviews what guidance exists and what else may be needed for review of products like MPTs that address two (or more) indications, including those with a single active, two actives, and multiple components. This meeting identified some of the specific opportunities and challenges for the regulatory pathway for MPTs, and helped the Council chart next steps for its work in this area. The lively and productive discussion helped inform how best to facilitate regulatory approval for MPTs for sexual and reproductive health, a critical component in developing and delivering these urgently needed products to women.

DOI

doi.org/10.31899/pgy2.1046

Language

English

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