When Pandemic Ends, EUA Recipients May Face Litigation And Enforcement Actions
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.
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The US Department of Health and Human Services is offering some legal protection to developers of devices and diagnostics for use in the fight against the novel coronavirus.
FDA concluded that original formulation of brain hemorrhage treatment was not discontinued for safety or effectiveness reasons, saying Arbor had other options to reduce risk of confusion between the new and original formulations. But the sponsor argues that withdrawal was part of FDA-approved risk mitigation plan.