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Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
During the 2022 mpox outbreak, tecovirimat was accessed through an expanded access investigational new drug (EA-IND) protocol. We leveraged a unique public/private hospital partnership in New York City to create a novel infrastructure to navigate the EA-IND’s regulatory requirements and rapidly prov...
Autores principales: | Mgbako, Ofole, Chan, Justin, Pitts, Robert A., DiLorenzo, Madeline A., Knutsen, Dorothy, Mazo, Dana |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Cambridge University Press
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369430/ https://www.ncbi.nlm.nih.gov/pubmed/37502253 http://dx.doi.org/10.1017/ash.2023.194 |
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