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Coronavirus (COVID-19) Update: May 28, 2021

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

  • This week, FDA launched the Medical Countermeasures Initiative (MCMi) Program Replace report which showcases FDA’s work annually to organize for all sorts of public well being emergencies, together with COVID-19. This report, overlaying fiscal 12 months 2020, features a snapshot of FDA’s COVID-19 response through the reporting interval.
  • As a part of the FDA’s effort to guard customers, on Might 27, the company issued a warning letter collectively with the Federal Commerce Fee to Oclo Nanotechnology for promoting unapproved chlorine dioxide merchandise with unproven COVID-19 claims. FDA continues to warn customers to not drink chlorine dioxide merchandise together with “OCLO 3000.” Ingesting any chlorine dioxide product may cause nausea, vomiting, diarrhea and signs of extreme dehydration. Customers involved about COVID-19 ought to seek the advice of with their well being care supplier.
  • On Might 27, 2021, the FDA issued an Replace: FDA Recommends Transition from Use of Non-NIOSH-Authorised and Decontaminated Disposable Respirators – Letter to Well being Care Personnel and Services. The FDA is recommending well being care personnel and services transition away from disaster capability conservation methods, equivalent to utilizing non-NIOSH-approved disposable respirators, together with imported respirators equivalent to KN95s. This suggestion is a follow-up to the April 9, 2021, letter by which the FDA beneficial a transition away from decontamination or bioburden-reduction techniques for cleansing and disinfecting disposable respirators which have been being reused by well being care personnel.
  • Testing updates:
    • As of at this time, 379 exams and pattern assortment units are approved by the FDA underneath emergency use authorizations (EUAs). These embrace 274 molecular exams and pattern assortment units, 80 antibody and different immune response exams and 25 antigen exams. There are 51 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 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 516 revisions to EUA authorizations.

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Boilerplate

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