Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.
Antimicrobial stewardship & healthcare epidemiology : ASHE（2023）
Abstract
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.
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Key words
investigational new drug protocol,tecovirimat,nyc mpox,public–private hospital partnership
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