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Premarket Approval For COVID-19 Test Is US FDA's First For OTC Respiratory Diagnostic

 
• By Malcolm Spicer

FDA’s first premarket approval of OTC test for any respiratory illness went to first firm to receive an EUA for at-home molecular COVID-19 test, Cue Health, which had received $481m from agency to spur its diagnostics development.

• Source: Shutterstock

The first OTC COVID-19 test authorized through the Food and Drug Administration’s premarket review pathway, not on an emergency waiver, also is the first at-home test for any respiratory illness the agency authorized using its traditional evaluation process.

The FDA’s first premarket approval of an OTC test for any respiratory illness went to the first firm to receive an emergency use authorization for an at-home molecular COVID-19 test, Cue Health Inc

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Debate On FDA User Fee Reauthorization Begins To Take Shape

 
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