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May 14, 2020

Emergency Use Authorization of Remdesivir: The Need for a Transparent Distribution Process

Author Affiliations
  • 1Divisions of Infectious Diseases and Organ Transplantation, Northwestern University Feinberg School of Medicine, Chicago, Illinois
  • 2Division of Infectious Diseases, Duke University School of Medicine, Durham, North Carolina
  • 3Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center and Tufts University School of Medicine, Boston, Massachusetts
JAMA. 2020;323(23):2365-2366. doi:10.1001/jama.2020.8863

On February 4, 2020, the Secretary of the US Department of Health and Human Services (DHHS) determined that there was a public health emergency due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). On March 27, 2020, the DHHS secretary declared that circumstances existed to justify the authorization of emergency use of drugs and biologics during the coronavirus disease 2019 (COVID-19) outbreak, pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act.1

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