ABSTRACT

[Letter Revoking Emergency Use Authorization (EUA) of Chloroquine Phosphates Supplied from the Strategic National Stockpile for Treatment of COVID-19 in Certain Hospitalized Patients]   [open pdf - 570KB]

From the Document: "Like BARDA's earlier request to FDA to issue the EUA [Emergency Use Authorization], BARDA's [Biomedical Advanced Research and Development Authority] request to revoke the EUA is part of a collaborative, USG [United States Government]-interagency effort to rapidly respond to this continuously evolving public health emergency. Today's request to revoke is based on new information, including clinical trial data results, that have led BARDA to conclude that this drug may not be effective to treat COVID-19 [Coronavirus Disease 2019] and that the drug's potential benefits for such use do not outweigh its known and potential risks. [...] Under section 564(c)(2) of the Act, an EUA may be issued only if FDA concludes 'that, based on the totality of scientific evidence available to the Secretary, including data from adequate and well-controlled clinical trials, if available, it is reasonable to believe that: (A) the product may be effective in diagnosing, treating, or preventing--(i) such disease or condition [….]; and (B) the known and potential benefits of the product, when used to diagnose, prevent, or treat such disease or condition, outweigh the known and potential risks of the product […].' As explained in the attached memorandum, based on a review of new information and a reevaluation of information available at the time the EUA was issued, FDA now concludes that these criteria are no longer met."

Publisher:
Date:
2020-06-15
Series:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
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