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Coronavirus (COVID-19) Update: May 7, 2021

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For Speedy Launch:

The U.S. Meals and Drug Administration immediately 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 shoppers, on Might 6, 2021, the company issued a warning letter to Disinfect & Defend for promoting an unapproved product with fraudulent COVID-19 claims. Customers involved about COVID-19 ought to seek the advice of with their well being care supplier.
  • Testing updates:
    • As of immediately, 370 assessments and pattern assortment gadgets are licensed by the FDA beneath emergency use authorizations (EUAs). These embody 270 molecular assessments and pattern assortment gadgets, 76 antibody and different immune response assessments, and 24 antigen assessments. 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 take a look at, two antigen prescription at-home assessments, 4 antigen over-the-counter (OTC) at-home assessments, and two molecular OTC at-home assessments.
    • The FDA has licensed 9 antigen assessments and three molecular assessments for serial screening packages. The FDA has additionally licensed 483 revisions to EUA authorizations.

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Boilerplate

The FDA, an company throughout the U.S. Division of Well being and Human Companies, protects the general public well being by assuring the security, effectiveness, and safety of human and veterinary medication, vaccines and different organic merchandise for human use, and medical gadgets. The company is also chargeable for the security 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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