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FDA Emergency Use Authorization (EUA)

An Emergency Use Authorization (EUA) in the United States is an authority granted to the Food and Drug Administration (FDA) under sections of the Federal Food, Drug, and Cosmetic Act as added to and amended by various Acts of Congress, including by the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA).

The Emergency Use Authorization (EUA) authority allows the FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.

During the COVID-19 pandemic, the FDA has issued many EUAs for tests as well as treatments, including convalescent plasma.

New Class of IVD Firms Wants to Serve POCT in Near-Patient Settings

CEO SUMMARY: Our second installment in this series describes an emerging new clas…

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Insurers Get Aggressive with Years-Old Audits, Searching for Lab Overpayments

This is an excerpt of a 1,971-word article in the July 26, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Not only are health insurers looking back to find lab overpayments and funds paid erroneously, but…

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Insurers Get Aggressive with Years-Old Audits

CEO SUMMARY: Not only are health insurers looking back to find overpayments and funds paid erroneously, but payers also are requiring documentation for overpayments. If clinical labs and anatomic pathology groups do not appeal such claims quickly, they may be liable for any amount i…

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Genetic Testing Continues to Grow in Volume and Complexity

This is an excerpt of a 1,333-word article in the July 26, 2021 issue of  THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Getting paid for genetic testing continues to be a challenge. This is true for both payers and the…

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Artificial Intelligence Is Ready to Deliver for Labs

CEO SUMMARY: Artificial intelligence (AI) may be one of the most over-used terms to describe a host of different applications, software tools, and products. However, during the past year, some truly revolutionary digital tools are now in use by a small number of innovative clinical laboratories…

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Amazon Now Interested in Home Testing Services

CEO SUMMARY: In the past year, internet retailing giant Amazon has built sizeable clinical laboratories in the United States and the United Kingdom. Now it has regulatory clearance to sell a molecular COVID-19 test to consumers for home collection. Comments made in the past month by…

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NorDx Lab Started COVID Preparation in 2019

This is an excerpt of a 2,995-word article in the December 7, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testin…

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Memphis Path Lab Pivots to COVID, Pooled Testing

CEO SUMMARY: When routine testing volume declined sharply last winter and spring, one of the nation’s largest anatomic pathology groups added testing for COVID-19 and boosted revenue significantly. Since then, the laboratory has become the first in the nation to gain an Emergency …

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NorDx Lab Started to Prepare for COVID-19 Testing in 2019

CEO SUMMARY: In a remarkable example of prescience, informed by decades-long experience in clinical lab testing and past epidemics, the president of NorDx Laboratories in Maine saw the December news accounts of a widespread outbreak of a new respiratory disease in China. He warned h…

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Will HHS Ruling on COVID-19 LDTs Be Good or Bad for Lab Reimbursement?

This is an excerpt of a 1,028-word article in the September 14, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an …

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