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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Bibliographic Details
Main Authors: Ofole Mgbako, Justin Chan, Robert A. Pitts, Madeline A. DiLorenzo, Dorothy Knutsen, Dana Mazo
Format: Article
Language:English
Published: Cambridge University Press 2023-01-01
Series:Antimicrobial Stewardship & Healthcare Epidemiology
Online Access:https://www.cambridge.org/core/product/identifier/S2732494X23001948/type/journal_article