Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public–private hospital partnership during the 2022 NYC mpox outbreak

Autor: Ofole Mgbako, Justin Chan, Robert A. Pitts, Madeline A. DiLorenzo, Dorothy Knutsen, Dana Mazo
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Antimicrobial Stewardship & Healthcare Epidemiology, Vol 3 (2023)
Druh dokumentu: article
ISSN: 2732-494X
DOI: 10.1017/ash.2023.194
Popis: 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.
Databáze: Directory of Open Access Journals