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Attorneys Expect COVID-19 ‘Enforcement Press’ Centered On PREP Act, Diagnostics

 
• By Elizabeth Orr

Three attorneys got out their crystal balls to forecast what device industry sectors may come in for enforcement scrutiny related to the COVID-19 pandemic.

The rapidly changing landscape around COVID-19 has left little time for federal enforcement actions. But that should shift as the vaccine becomes more widely used in coming months – and as it does, watch for products covered under the PREP Act, diagnostics, and emergency use authorization (EUA) products to come under scrutiny, a panel of attorneys recently said at a conference hosted by the Food and Drug Law Institute.

The Public Readiness and Preparedness (PREP) Act allows the secretary of the US Department of Health and Human Services (HHS) to provide legal immunity on the manufacture, development and distribution...

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