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When Pandemic Ends, EUA Recipients May Face Litigation And Enforcement Actions

 
• By Brenda Sandburg

Manufacturers face risk of whistle-blower suits and government enforcement actions when emergency use authorizations expire and pandemic recedes, attorneys say, but interaction with FDA and documentation may mitigate risk.

Risk Dial
Manufacturers face risks of litigation and enforcement actions in post-COVID world

Manufacturers benefited from regulatory flexibilities that allowed them to get COVID-19 products on the market at lightening speed. But they could face government enforcement actions and litigation once the public health emergency ends and emergency use authorizations (EUAs) for their products are terminated.

“In a post-COVID pandemic world, that period of flexibility and the sense of collective urgency will eventually draw to a...

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