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

• Главные авторы: Ofole Mgbako (Автор), Justin Chan (Автор), Robert A. Pitts (Автор), Madeline A. DiLorenzo (Автор), Dorothy Knutsen (Автор), Dana Mazo (Автор)
• Формат: ‌
• Опубликовано: Cambridge University Press, 2023-01-01T00:00:00Z.
• Предметы: article
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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...