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

Antimicrob Steward Healthc Epidemiol

Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA.

Published: June 2023

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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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC10369430PMC
http://dx.doi.org/10.1017/ash.2023.194DOI Listing

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