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Coronavirus (COVID-19) Update: May 11, 2021

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The U.S. Meals and Drug Administration (FDA) continued to take motion within the ongoing response to the COVID-19 pandemic:

  • As a part of the FDA’s effort to guard shoppers, on Could 6, 2021, the company issued a warning letter to Covalon Applied sciences Inc. for promoting unapproved merchandise with fraudulent COVID-19 claims. Shoppers involved about COVID-19 ought to seek the advice of with their well being care supplier. 
  • The company has up to date its FDA COVID-19 Response At-A-Look Abstract, which supplies a fast have a look at information, figures and highlights on the FDA’s response efforts.
  • On Could 10, the FDA issued a press launch about FDA’s enlargement of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to incorporate people 12 by means of 15 years of age. The next paperwork have been up to date to replicate the authorization of the vaccine within the adolescent inhabitants:
  • As well as, the FDA added a query, “What knowledge did the FDA consider to assist Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine in people 12 by means of 15 years of age?”, to the Pfizer-BioNTech COVID-19 Incessantly Requested Questions webpage. The FDA is at present engaged on translating the up to date Reality Sheet for Recipients and Caregivers in a number of languages.
  • Testing updates:
    • As of in the present day, 370 assessments and pattern assortment units are licensed by the FDA below emergency use authorizations (EUAs). These embody 270 molecular assessments and pattern assortment units, 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’s 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 applications.
    • The FDA has additionally licensed 488 revisions to EUA authorizations.

The FDA, an company inside 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 units. 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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