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    US Food and Drug Administration (FDA) Emergency Use Authorization: Glass Half Full or Glass Half Empty

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    Authors
    Guharoy, Roy
    Krenzelok, Edward P.
    UMass Chan Affiliations
    Infectious Diseases
    Document Type
    Journal Article
    Publication Date
    2020-10-26
    Keywords
    emergency use authorization
    convalescent plasma
    public trust
    randomized control trial
    COVID-19
    Clinical Trials
    Health Services Administration
    Infectious Disease
    Pharmacy Administration, Policy and Regulation
    Virus Diseases
    
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    Link to Full Text
    https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665427/
    Abstract
    Recently, the Food and Drug Administration (FDA) issued emergency use authorization (EUA) of convalescent plasma (CP) for the treatment of COVID-19 hospitalized patients based on a non-peer reviewed open label observational study. Issuance of an EUA without a proven randomized control trial (RCT) sets a dangerous precedent since the premature action drives health care providers and patients away from RCTs that are essential for determining the efficacy and safety of CP. More caution should have been taken based on what was learned from the recently rescinded EUA of hydroxychloroquine and chloroquine debacle which was approved initially based on an anecdotal report. The FDA approval process for determining efficacy and safety must be based solely on data from RCTs to sustain public and professional trust for future treatment or vaccine efforts to be successful.
    Source

    Guharoy R, Krenzelok EP. FDA Emergency Use Authorization: Glass Half Empty? Clin Infect Dis. 2020 Oct 26:ciaa1653. doi: 10.1093/cid/ciaa1653. Epub ahead of print. PMID: 33104216; PMCID: PMC7665427. Link to article on publisher's site

    DOI
    10.1093/cid/ciaa1653
    Permanent Link to this Item
    http://hdl.handle.net/20.500.14038/41613
    PubMed ID
    33104216
    Related Resources

    Link to Article in PubMed

    ae974a485f413a2113503eed53cd6c53
    10.1093/cid/ciaa1653
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    UMass Chan Faculty and Researcher Publications

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