Latest (04-17-2020) News Round-Up and Digest from Food and Drug Administration (FDA)

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Original official link from FDA

The U.S. Food and Drug Administration  announced  a few latest actions regarding COVID-19 on Friday (04-17-2020):

  • The National Institutes of Health (NIH) and the Foundation for the NIH will be partner with FDA, which will facilitate general research, development, clinical trial and regulation and speed-up the overall process
  • On Friday,  the Genesis II Church of Health and Healing (Genesis) and four individuals associated with the entity, were required to stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes many other diseases. Also FDA and FTC issued a warning letter to Nova Botanix LTD DBA CanaBD, which sells unapproved and misbranded cannabidiol (CBD) products for sale in the U.S. with misleading claims of safety and effect on COVID-19
  • On Friday, FDA announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose. As part of this effort, U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing.
  • The FDA issued a new emergency use authorization (EUA) for Extracorporeal Blood Purification (EBP) to ExThera Medical Corporation for emergency use of the Seraph 100 Microbind Affinity Blood Filter device to treat patients 18 years of age or older with confirmed COVID-19 admitted to the intensive care unit with confirmed or imminent respiratory failure to reduce pathogens and inflammatory mediators from the bloodstream. The Seraph 100 Microbind Affinity Blood Filter device is an extracorporeal broad-spectrum sorbent hemoperfusion device that is designed to reduce bacteria, viruses, toxins, cytokines and other inflammatory mediators from whole blood.
  • Diagnostics update to date:
    • During the COVID-19 pandemic, the FDA has worked with more than 320 test developers who have said they will be submitting emergency use authorizations (EUA) requests to FDA for tests that detect the virus.
    • To date, the FDA has issued 39 individual emergency use authorizations for test kit manufacturers and laboratories. In addition, 16 authorized tests have been added to the EUA letter of authorization for high complexity molecular-based laboratory developed tests (LDTs).
    • The FDA has been notified that more than 190 laboratories have begun testing under the policies set forth in our COVID-19 Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency Guidance.
    • The FDA also continues to keep its COVID-19 Diagnostics FAQ up to date.

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