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Coronavirus (COVID-19) Update: May 14, 2021

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The U.S. Meals and Drug Administration as we speak introduced the next actions taken in its ongoing response effort to the COVID-19 pandemic:

  • As a part of the FDA’s effort to guard customers, on April 29, 2021 the company issued a warning letter to Crown Wellness, Inc. for, amongst different issues, promoting an unapproved product with COVID-19 claims. Shoppers involved about COVID-19 ought to seek the advice of with their well being care supplier.
  • Testing updates:
    • As of as we speak, 372 exams and pattern assortment gadgets are approved by the FDA below emergency use authorizations (EUAs). These embrace 270 molecular exams and pattern assortment gadgets, 78 antibody and different immune response exams, and 24 antigen exams. There are 49 molecular authorizations and one antibody authorization that can be utilized with home-collected samples. There may be one molecular prescription at-home check, two antigen prescription at-home exams, 4 antigen over-the-counter (OTC) at-home exams, and two molecular OTC at-home exams.
    • The FDA has approved 9 antigen exams and 4 molecular exams for serial screening packages.
      The FDA has additionally approved 498 revisions to EUA authorizations.

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The FDA, an company throughout the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the protection, effectiveness, and safety of human and veterinary medicine, vaccines and different organic merchandise for human use, and medical gadgets. The company is also liable for the protection and safety of our nation’s meals provide, cosmetics, dietary dietary supplements, merchandise that give off digital radiation, and for regulating tobacco merchandise.


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