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
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author Mgbako, Ofole
Chan, Justin
Pitts, Robert A.
DiLorenzo, Madeline A.
Knutsen, Dorothy
Mazo, Dana
author_facet Mgbako, Ofole
Chan, Justin
Pitts, Robert A.
DiLorenzo, Madeline A.
Knutsen, Dorothy
Mazo, Dana
author_sort Mgbako, Ofole
collection PubMed
description 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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spelling pubmed-103694302023-07-27 Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak Mgbako, Ofole Chan, Justin Pitts, Robert A. DiLorenzo, Madeline A. Knutsen, Dorothy Mazo, Dana Antimicrob Steward Healthc Epidemiol Commentary 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. Cambridge University Press 2023-06-29 /pmc/articles/PMC10369430/ /pubmed/37502253 http://dx.doi.org/10.1017/ash.2023.194 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by/4.0/This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
spellingShingle Commentary
Mgbako, Ofole
Chan, Justin
Pitts, Robert A.
DiLorenzo, Madeline A.
Knutsen, Dorothy
Mazo, Dana
Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
title Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
title_full Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
title_fullStr Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
title_full_unstemmed Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
title_short Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak
title_sort navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 nyc mpox outbreak
topic Commentary
url 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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