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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.

Global IVD Companies Report Second Quarter 2024 Earnings

IN THE SECOND QUARTER OF 2024, in vitro diagnostics (IVD) companies reported solid revenues as well as new tests, analyzers, and automation. Most of the IVD companies boosted diagnostic sales in low single digit amounts. During the earnings calls, financial analysts asked company leade…

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OIG Reports Its Findings about CDC’s First COVID Test Problems

ONE MAJOR FAILURE BY FEDERAL AGENCIES in the first days of the COVID-19 pandemic was the development and release of an inaccurate and unreliable SARS-CoV-2 test, intended for use by public health labs. This was the finding of the U.S. Department of Health and Human Services (HHS) …

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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…

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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 …

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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…

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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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