FDA Busy Week Updates: From Notices to Clinical Labs & Providers to Vaccine Transparency to Cracking Down on COVID-19 Quackery

FDA Busy Week Updates From Notices to Clinical Labs & Providers to Vaccine Transparency to Cracking Down on COVID-19 Quackery

The U.S. Food and Drug Administration (FDA) remains very busy, as the world’s leading food and drug regulatory agency, contributing to the war against COVID-19.  Busy on a number of fronts, the agency recently alerted clinical laboratory staff and health care providers that  genetic variants of SARS-CoV-2 may possibly lead to false negative results with molecular tests for COVID-19 via a “Letter to Clinical Laboratory Staff and Health Care Providers.” This past week, the FDA released a new webpage “Moderna COVID-19 Vaccine Frequently Asked Questions” offering more transparency to the public about the review of the Moderna COVID-19 vaccine now authorized for emergency use. The agency issued a warning letter to actors in the economy commercially marketing products as “preventions” or “treatments” for COVID-19. This was in parallel with a U.S. District Court in Georgia granting a consent decree of permanent injunction against Fusion Health and Vitality LLC, Fusion Ionz LLC and Matthew Ryncarz for illegally commercially promoting products containing vitamin D and hordenine HCl, as COVID treatments. The FDA reports that to date 311 tests and sample collection devices are authorized by ...

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