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FDA News Release

Coronavirus (COVID-19) Update: Daily Roundup June 11, 2020

For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • FDA issued an FDA Voices, titled Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19, which explains that the FDA’s work to advance treatments for rare diseases and help ensure continuity of care for patients with those diseases continues to be a top priority during the COVID-19 public health emergency.
  • As part of the FDA’s mission to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19-related products. The FDA letter warned the seller, www.outoftheboxremedies.com, which offers iodine products for sale in the United States, citing misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 in people. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.
  • On June 10, 2020, the FDA posted FAQs to address questions related to the design, evaluation, labeling, and marketing of hospital beds, stretchers, and mattresses during the COVID-19 public health emergency.
  • Testing updates:
    • To date, the FDA has authorized 135 tests under EUAs, which include 114 molecular tests, 20 antibody tests, and 1 antigen test.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Lee Herring

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