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...

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Detalles Bibliográficos
Autores principales: Mgbako, Ofole, Chan, Justin, Pitts, Robert A., DiLorenzo, Madeline A., Knutsen, Dorothy, Mazo, Dana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Cambridge University Press 2023
Materias:
Commentary
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
Descripción
Sumario: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 provide tecovirimat to patients.

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