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

• Main Authors: Ofole Mgbako (Author), Justin Chan (Author), Robert A. Pitts (Author), Madeline A. DiLorenzo (Author), Dorothy Knutsen (Author), Dana Mazo (Author)
• Format: Book
• Published: Cambridge University Press, 2023-01-01T00:00:00Z.
• Subjects: article
• Online Access: Connect to this object online.

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...