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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.
IVD Firms Prepare for OTC, Home Test Market Expansion
CEO SUMMARY: With public interest in home testing growing, some IVD manufacturers are preparing to serve a fast-expanding market for over-the-counter and at-home tests. IVD firms are banking on the…
How Genomic Testing Labs Can Improve Their Relationships with Payers
CEO SUMMARY: For payers and health plans, it may be a matter of trust that initially curtails speedy reimbursement of new and novel genomic test claims. A panel …
Post-COVID: Repurposing Excess PCR Instruments
CEO SUMMARY: Currently, there are hospital, health system, and independent clinical laboratories that have between two and five different PCR testing platforms. These analyzers were acquired during the pandemic as one way to increase the daily number of SARS-CoV-2 their labs could p…
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…
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…
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…
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…
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…
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…
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…
CURRENT ISSUE
Volume XXX, Number 17 – December 4, 2023
In this issue, The Dark Report discusses the impact of artificial intelligence-powered solutions. The Dark Report suggests that it is timely for lab managers at all levels of the organization to begin learning about the field of artificial intelligence. In addition to this topic, discover how labs should be prepared for data to dominate diagnostics, understand that CLIA lab directors must monitor delegated duties, and stay informed about the latest regulatory and IVD updates.
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