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FDA Targets Makers Of OTC COVID-19 Tests With Tweaks To 2 EUA Templates

 
• By Shawn M. Schmitt

The US agency made changes to two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for over-the-counter use and to offer “flexible study recommendations.”

FDA entrance sign 2016

Developers of COVID-19 tests for over-the-counter use should look to two revised emergency use authorization templates from the US Food and Drug Administration as they prepare their EUA applications to the agency.

The templates, “Molecular and Antigen Home Use Test Template” and “Supplemental Template for Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing,” were updated by the...

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