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Full-Text Articles in Medicine and Health Sciences
Day Of Dialogue On Multipurpose Prevention Technologies: Toward Clarity In Nomenclature, Martha Brady, C. Elizabeth Mcgrory
Day Of Dialogue On Multipurpose Prevention Technologies: Toward Clarity In Nomenclature, Martha Brady, C. Elizabeth Mcgrory
Poverty, Gender, and Youth
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 …
Facilitating Regulatory Approval Of Multipurpose Prevention Technologies For Sexual And Reproductive Health, Martha Brady
Facilitating Regulatory Approval Of Multipurpose Prevention Technologies For Sexual And Reproductive Health, Martha Brady
HIV and AIDS
This brief describes multipurpose prevention technologies (MPTs) that address women's sexual and reproductive health (SRH) needs, and how to go about facilitating regulatory approval of this technology. It outlines a strategic framework to examine current regulatory guidance, as well a product development pathway to bring MPTs to market.
Constructing A Critical Path For Product Development, Commercialization, And Access, Martha Brady
Constructing A Critical Path For Product Development, Commercialization, And Access, Martha Brady
HIV and AIDS
This brief discusses the Council's health technologies development and the product development path from conceptualization to market. It defines the steps in the Critical Path Framework, and examines activities at the preclinical and clinical stage.