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NIH, CDC Distributing OTC COVID-19 Tests In US Study On Reducing Community Transmission

 
• By Malcolm Spicer

NIH pays for 2 million Quidel QuickVue tests in a program it is conducting with the CDC to determine whether frequent self-administered testing helps reduce community transmission of SARS-CoV-2.

A COVID-19 test recently cleared for over-the-counter (OTC) sales in the US will do more than expand consumer access to tests for infections.

The National Institutes of Health is paying for 2 million Quidel QuickVue At-Home tests to use in a program it’s conducting with the Centers for Disease Control to determine...

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Get Ready For International Harmonization Before Approaching QMSR Deadline, Says Regulatory Expert

 
• By Brian Bossetta

During MD&M East last week, regulatory consultant Darren Reeves reminded device manufacturers that the time to get ready to comply with the new Quality Management System Regulation is now.

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