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Full-Text Articles in Diseases
Nonclinical Development Needs And Regulatory Requirements For Multipurpose Prevention Technologies: A Primer, Joseph W. Romano, Martha Brady, Judy Manning
Nonclinical Development Needs And Regulatory Requirements For Multipurpose Prevention Technologies: A Primer, Joseph W. Romano, Martha Brady, Judy Manning
HIV and AIDS
This summary outlines key development elements that will be necessary for various configurations of multipurpose prevention products for the simultaneous prevention of HIV, sexually transmitted infections, and/or pregnancy.
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.
What Regulatory Guidance Exists For Multipurpose Prevention Technologies (Mpts)? A Review Of Key Guidance Documents And Their Applicability To Mpts, Martha Brady, Heeyoung Park
What Regulatory Guidance Exists For Multipurpose Prevention Technologies (Mpts)? A Review Of Key Guidance Documents And Their Applicability To Mpts, Martha Brady, Heeyoung Park
HIV and AIDS
This brief reviews regulatory guidance documents and how they may apply to multi-purpose technologies (MPTs). It examines guidance documents from the Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The brief concludes by anticipating increased interactions with US regulatory agencies in hopes of finding new regulatory pathways that address MPTs specifically.