FDA To Expedite EUA For Serial Screening Of Asymptomatic COVID-19

By Kelly Lienhard / March 16, 2021 at 7:58 PM
FDA is open to authorizing COVID-19 tests that can be used to regularly screen asymptomatic individuals at businesses and schools or at home, even if the tests have not been validated for use in asymptomatic patients, the agency announced Tuesday (March 16) , saying it hopes the streamlined pathway to market will expand availability of screening tests and bolster testing programs. The agency’s new expedited pathway is laid out in an emergency use authorization template for molecular and antigen tests...


Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.