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FDA Updates COVID-19 Test Policy; Shifts Focus From EUAs

 
• By Brian Bossetta

As part of a policy revamp, the US FDA is encouraging COVID-19 test developers to pursue traditional premarket review pathways rather than emergency use authorizations.

COVID-19 Testing Flag
• Source: Shutterstock

More than two years into the COVID-19 pandemic, the Food and Drug Administration is adjusting its thinking on how it approves diagnostics, even while emphasizing testing is still an essential weapon in the federal government’s fight to stop the virus.

“Testing remains one of the key pillars in combatting the COVID-19 pandemic,” said Jeff Shuren, director of the FDA’s

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