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