Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic

Role of CTSA institutes and academic medical centers in facilitating preapproval access to investigational agents and devices during the COVID-19 pandemic

Abstract Introduction: With no approved treatments for COVID-19 initially available, the Food and Drug Administration utilized multiple preapproval pathways to provide access to investigational agents and/or medical devices: Expanded Access, Emergency Use Authorizations, and Clinical Trials. Regul...

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Bibliographic Details
Main Authors: Misty Gravelin, Jeanne Wright, M.E. Blair Holbein, Marlene Berro, Jennifer S. Brown, George A. Mashour, Kevin J. Weatherwax
Format: Article
Language:English
Published: Cambridge University Press 2021-01-01
Series:Journal of Clinical and Translational Science
Subjects:
COVID-19
CTSA
academic medical centers
regulatory support
preapproval access
Online Access:https://www.cambridge.org/core/product/identifier/S2059866121000157/type/journal_article

Internet

https://www.cambridge.org/core/product/identifier/S2059866121000157/type/journal_article

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