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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.
COVID-19 Serology Test Review: FDA Says 8 of 11 Tests Fail
CEO SUMMARY: After introducing some 200 serological assays onto the market in March and April with little or no review, as of this writing the FDA website lists only 77 serology tests. Of that number, 11 assays have been evaluated independently and eight of those 11 have been pulled from…
COVID-19 Serology Test Claims 98.8% Accuracy
CEO SUMMARY: When it announced its new antibody test for the novel coronavirus SARS-CoV-2 on May 3, Roche Holdings explained that its sensitivity level after 14 days was 100%, which is an important point to understand about the test. When assessing Roche’s claims, two expert…
Lab, Path Finances Crash; Next Test Wave: Serology
CEO SUMMARY: For clinical laboratories and anatomic pathology groups, the day-by-day impact of the COVID-19 pandemic is unfolding much like Hurricane Katrina hitting New Orleans in 2005. Every 24 hours, labs get unwelcome news, along with uncertainty about whether it will …
Chicago Lab Launches LDT, Finds 20% Positive
CEO SUMMARY: After seeing the novel coronavirus spread quickly in China, staff in the Department of Pathology and Laboratory Medicine developed a test to identify the pathogen in patients in Chicago and its suburbs. With the CDC’s assay in hand, it started work on its ow…
At the Epicenter, Northwell’s COVID-19 Lab Data Adds Value
CEO SUMMARY: This intelligence briefing provides a valuable look inside a clinical laboratory that is at ground zero in a city and state that is experiencing the nation’s most intense and fastest-moving incidence of COVID-19, the novel coronavirus. Lab leadership granted Th…
Northwell Lab Team Validates COVID-19 Test on Fast Timeline
CEO SUMMARY: Clinical labs are working with haste to test for the novel coronavirus, also called nCoV and SARS-CoV-2. Their efforts to prepare for high capacity testing for viral respiratory illness include validating molecular tests for the newly-identifie…
Northwell Lab Team Validates Novel Coronavirus Test on Fast Timeline
This is an excerpt of a 2,375-word article in the March 9, 2020 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Clinical labs are working with haste to develop a no…
CURRENT ISSUE
Volume XXXI, No. 5 – April 8, 2024
The fragmentation of consumer markets is reflected in clinical lab services, and The Dark Report examines this trend and how it will impact labs in the coming years. Also, The Dark Report notes that the FDA has issued a controversial memo to reclassify many high-risk IVD assays.
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