Archive for: Emergency Use Authorization

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Diagnostics

FDA updates its FAQ on COVID-19 testing and gives EUA to additional tests

On March 28, FDA again updated its FAQ regarding specimen collection for COVID-19 testing.

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Diagnostics

FDA updates its FAQ on COVID-19 testing and gives EUA to additional tests

On March 23, FDA updated its FAQ regarding specimen collection for COVID-19 testing.

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Diagnostics

FDA gives EUA for first point-of-care COVID-19 test

Since March 19, the FDA announced four additional Emergency Use Authorizations granted for diagnostic tests for COVID-19 including the first point-of-care test.

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Diagnostics

FDA gives EUA to additional tests for diagnostic testing for COVID-19

Since March 17, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19.

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Diagnostics

FDA gives EUA to additional tests and issues policy on diagnostic testing for COVID-19

Since March 13, the FDA announced three additional Emergency Use Authorizations granted for diagnostic tests for COVID-19.

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Diagnostics

FDA took two additional steps in response to the coronavirus (COVID-19) outbreak

On March 12, 2020, the FDA took two additional steps to address the coronavirus (COVID-19) outbreak.

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Diagnostics

FDA Posts a Number of New Items Related to Coronavirus

On February 29, 2020, the FDA issued a new guidance document (immediately in effect) on its policy for diagnostic testing in laboratories certified to perform high complexity testing under CLIA prior to EUA for COVID-19 during the public health emergency.

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