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Navigating the expanded access investigational new drug protocol for tecovirimat: lessons learned from a public-private hospital partnership during the 2022 NYC mpox outbreak.
Mgbako, Ofole; Chan, Justin; Pitts, Robert A; DiLorenzo, Madeline A; Knutsen, Dorothy; Mazo, Dana.
Afiliación
  • Mgbako O; Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA.
  • Chan J; Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA.
  • Pitts RA; Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA.
  • DiLorenzo MA; Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA.
  • Knutsen D; Division of Infectious Diseases and Immunology, Department of Medicine, NYU Langone Health, New York, NY, USA.
  • Mazo D; Division of Infectious Diseases, Department of Medicine, New York City Health + Hospitals/Bellevue, New York, NY, USA.
Antimicrob Steward Healthc Epidemiol ; 3(1): e110, 2023.
Article en En | MEDLINE | ID: mdl-37502253
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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Texto completo: 1 Base de datos: MEDLINE Idioma: En Revista: Antimicrob Steward Healthc Epidemiol Año: 2023 Tipo del documento: Article
Texto completo
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Base de datos: MEDLINE Idioma: En Revista: Antimicrob Steward Healthc Epidemiol Año: 2023 Tipo del documento: Article