For immediate release:

Today, the U.S. Food and Drug Administration provides an at-a-glance summary of news from the agency:

  • Today, the FDA released a new resource, COVID-19 Home Diagnostic Tests, which provides a list of all FDA-cleared over-the-counter COVID-19 home diagnostic tests. Testing and other protective measures like wearing a mask and getting vaccinated against COVID-19 are key to stopping the spread of COVID-19. OTC COVID-19 at-home diagnostic tests play a key role in the fight against COVID-19.
  • On February 18, the FDA approved an expanded indication for the Medtronic Freezor and Freezor Xtra Cardiac Cryoablation Catheters to include children at least 2 years of age and older. This approval expands the indication for cryoablation in atrioventricular nodal reentrant tachycardia (AVNRT), a condition that causes episodes of abnormally rapid heartbeats that often begin and end suddenly. The device, used in a minimally invasive surgical procedure, uses extremely cold gas to permanently freeze and destroy a tiny area of ​​the heart responsible for the abnormally rapid heartbeat. The approval also extends cryothermal mapping capability to the Freezor Xtra Catheter. Cryothermal mapping allows the cardiologist to verify the tissue that needs to be treated before permanently destroying that tissue.
  • On February 18, the FDA alerted the public that several categories of FDA-regulated products purchased from January 1, 2021 through present at Family Dollar stores in Alabama, Arkansas, Louisiana, Mississippi, Missouri and Tennessee could be dangerous for consumers. use. The affected products originated from the company’s distribution facility in West Memphis, Arkansas, where an FDA inspection revealed unsanitary conditions, including rodent infestation, that could contaminate many products. The FDA has worked with the company to initiate a voluntary recall of the affected products.
  • On February 15, as part of the FDA’s efforts to protect consumers, the agency sent warning letters to the operators of two websites, https://extrapharmacy.ru/ and https://www.rxshopmd .com/ for unapproved and mislabeled marketing. drugs for multiple illnesses, including COVID-19. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain entirely different ingredients. Consumers can visit BeSafeRx to learn how to buy drugs online safely. Consumers concerned about COVID-19 should consult their healthcare provider. to find out how to buy medicines online safely. Consumers concerned about COVID-19 should consult their healthcare provider.
  • On February 11, as part of the FDA’s efforts to protect consumers, the agency sent a warning letter to CytoDyn Inc. for making statements in a promotional context that leronlimab, a drug that does not has not been approved or cleared by the FDA, is safe and effective for use in the treatment of COVID-19. Consumers concerned about COVID-19 should consult their healthcare provider.
  • COVID-19 testing updates:
    • To date, 420 tests and specimen collection devices are authorized by the FDA under Emergency Use Authorizations (EUAs). These include 290 molecular tests and sample collection devices, 85 antibody tests and other immune response tests and 45 antigen tests. There are 70 molecular clearances and one antibody clearance that can be used with home samples. There is one EUA for molecular prescription home testing, three EUAs for antigen prescription home testing, 15 EUA for over-the-counter (OTC) antigen home testing, and three EUA for home testing Molecular OTCs.
    • The FDA has authorized 26 antigen tests and 10 molecular tests for serial screening programs. The FDA also authorized 843 revisions to EUA clearances.

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The FDA, an agency of the United States Department of Health and Human Services, protects public health by ensuring the safety, efficacy, and safety of drugs, vaccines, and other biological products for human use, and medical devices. The agency is also responsible for the safety and security of the food supply, cosmetics, dietary supplements, electronic radiation emitting products and the regulation of tobacco products.