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COVID-19 Report for Life Sciences and Health Care Companies (UPDATED)

The COVID-19 Report is a compilation of coronavirus news, analysis, and insights from around the world to help life sciences and health care companies stay current in this challenging time. ...more

FDA authorizes first diagnostic test for screening people without known or suspected COVID-19 infection

On July 24, 2020, the U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use...more

COVID-19 Report for Life Sciences and Health Care Companies

In Tuesday's report: FDA issues first EUA for sample pooling, closes its COVID-19 hotline, and extends HCT/P enforcement discretion; a litigation team podcast on work return risks; Virginia establishes COVID-19 workplace...more

COVID-19 update: Facilitating diagnostic test availability for asymptomatic testing, sample pooling

On June 16, the U.S. Food and Drug Administration (FDA) posted updates to their Molecular Diagnostic Templates for developers that intend their assay to be used for pooled patient samples or for screening asymptomatic...more

Senate bill proposes laboratory developed tests to be regulated under CLIA process

U.S. Senator Rand Paul introduced legislation that would place laboratory developed testing procedures within the Clinical Laboratory Improvement Amendments (CLIA) process and assess the availability and utilization of...more

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