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On May 1, the US Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for remdesivir for the treatment of hospitalized adults and children with severe coronavirus disease 2019 (COVID-19). An EUA permits the use of an unapproved drug, biologic, or medical device and may be issued by the FDA when the secretary of Health and Human Services has declared a public health emergency “that has a significant potential to affect national security or the health and security of United States citizens living abroad.”1 As seen with the FDA’s recent revocation of the EUA for hydroxychloroquine, the agency has wide discretion to revoke or revise EUAs when appropriate for public health (the FDA does not have comparable authority to act so quickly with respect to drugs that have been approved).
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Sarpatwari A, Kaltenboeck A, Kesselheim AS. Missed Opportunities on Emergency Remdesivir Use. JAMA. 2020;324(4):331–332. doi:10.1001/jama.2020.11932
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