Stephanie Philbin

Stephanie Philbin

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FDA’s Updated Enforcement Policy for COVID-19 Tests: Key Takeaways for Developers of COVID-19 Laboratory Developed Tests and...

On November 15, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued the fifth edition of the Agency’s guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.”...more

12/7/2021  /  Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Enforcement , Food and Drug Administration (FDA) , Infectious Diseases , Laboratory Developed Tests , Manufacturers , Virus Testing
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