US FDA Updates Template For OTC COVID-19 Test Development
The US FDA’s most recent update is intended to help test makers provide validation data and other information to the agency for developing at-home diagnostic tests.
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Agency changes two of its emergency use authorization templates “to support authorization of more COVID-19 tests” for OTC use and to offer “flexible study recommendations.”
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.”