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US FDA Recommendations On Developing Serial COVID-19 Tests Could Accelerate OTC Approval

FDA published a supplemental template for molecular and antigen COVID-19 EUA sponsors with products to be used for serial testing, and a fact sheet that screening program organizers can use to pick the right test.

A take-home COVID-19 test kit and face mask

The US Food and Drug Administration has made available a development template with recommendations to streamline emergency use authorizations of screening tests for serial COVID-19 testing, which developers can consider before conducting certain performance evaluations with asymptomatic patients.

If the recommendations are followed, the FDA may grant an EUA for OTC distribution to certain point-of-care or at-home tests...

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