Darra James Coleman

Darra James Coleman

Maynard Nexsen

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Latest Posts › Food and Drug Administration (FDA)

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How Confident Should Consumers Be? Types of Tests and Recent Regulatory Actions to Enhance COVID-19 Testing Integrity

Entrepreneurs, scientists, and politicians all recognize the important role of testing for the Coronavirus Disease 2019 (COVID-19). Manufacturers and laboratories commenced the development of various types of tests almost as...more

10/26/2020  /  Centers for Medicare & Medicaid Services (CMS) , CLIA , Coronavirus/COVID-19 , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Infectious Diseases , Virus Testing

A Glimpse at Recent State and Federal COVID-19 Testing Developments

At both the state and federal level, COVID-19 testing is the focus of regulatory focus. On May 6, 2020, the South Carolina Department of Health and Environmental Control announced that it will conduct statewide COVID-19...more

5/13/2020  /  CLIA , Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA)
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