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In Shift, FDA Ordered to Provide 'Timely' EUA Reviews for COVID-19 Lab Developed Tests, MedTech Dive

Tuesday, November 17, 2020

MedTech Dive featured comments from Morgan Lewis partner Dennis Gucciardo in an article about the US Department of Health and Human Services directive to the US Food and Drug Administration to review requests for emergency use authorization for COVID-19 laboratory developed tests "in a timely manner.”  In the piece, Dennis highlights lingering legal questions regarding regulatory burden and the criteria for PREP Act liability immunity.

Read the full MedTech Dive article >>