FDA Renews EUA for Convalescent Plasma & Issues Cease & Desist for Unapproved Drugs & Covid Tests ...Middle East

Washington, DC…The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic: The FDA has reissued the August 23, 2020 emergency use authorization (EUA) for the emergency use of COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. The Letter of Authorization has been revised to add the Mount Sinai COVID-19 ELISA IgG Antibody Test as an acceptable test to be used for the purpose of qualifying high and low titer COVID-19 convalescent plasma in the manufacture of COVID-19 convalescent plasma. As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly

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