Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.
Antimicrob Steward Healthc Epidemiol
; 3(1): e110, 2023.
Article
en En
| MEDLINE
| ID: mdl-37502253
ABSTRACT
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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Base de datos:
MEDLINE
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En
Revista:
Antimicrob Steward Healthc Epidemiol
Año:
2023
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Article