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FDA COVID-19 Update

EUAs, Clinical Trial guidance updates, and Diagnostics update

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By: Kristin Brooks

Managing Editor, Contract Pharma

The following are some of the U.S. FDA’s actions taken, as of March 31, in its ongoing response effort to the COVID-19 pandemic: On March 28, 2020, the FDA issued an Emergency Use Authorization (EUA) to allow hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) to be distributed and used for certain hospitalized patients with COVID-19. On March 29, 2020, the FDA issued an immediately in effect guidance that outlines an enfo...

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