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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.

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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Is HHS Ruling on COVID-19 LDTs Negative for Lab Reimbursement?

WHILE SOME LABS CELEBRATE THE PERCEIVED FLEXIBILITY that comes from not having to get an emergency use authorization (EUA) for COVID-19 laboratory-developed tests (LDTs), there is a potential downside—difficulty getting reimbursed for the test. On Aug. 19, the Department of Health and Human S…

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September 14, 2020 Intelligence: Late-Breaking Lab News

Alphabet, Inc., the parent of Google, is expanding its COVID-19 testing activities. In recent months, Verily Life Sciences—a division of Alphabet devoted to research into life sciences—organized a clinical laboratory for COVID-19 testing. It obtained CLIA certification and is licensed wit…

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FDA Will Have No Authority Over Laboratory-Developed Tests, HHS Says

This is an excerpt of a 2,029-word article in the August 24, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implic…

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HHS ‘Stands Down’ FDA on Its Oversight of LDTs

CEO SUMMARY: A directive from the federal Department of Health and Human Services (HHS) may have long-lasting implications for the federal Food and Drug Administration’s efforts to assert regulatory oversight of laboratory-developed tests (LDTs). In a statement last week, HHS said t…

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Officials Differ on Value of COVID-19 Pooled Testing

CEO SUMMARY: Some experts on testing strategies support pooled testing because this method may support reopening by schools and businesses and thus bring the economy back. But other experts have raised questions about this strategy. Rules from the federal Centers for Medicare …

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FDA Says 8 of 11 Tests Fail in Serology Test Review

This is an excerpt of a 1,970-word article in the June 22, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review,…

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