TAG:

Food and Drug Administration

FDA Expected to Publish Proposed LDT Rule in August

CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…

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Despite COVID-19 Losses, IVD Executives Remain Upbeat

Continuing declines in COVID-19 test revenues was a common theme during the first quarte…

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Lab Execs Allegedly Lied to FDA about Faulty Tests

CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…

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What’s Next in 2023 for Clinical Laboratories?

AS YOU OPEN THIS ISSUE OF THE DARK REPORT, in New Orleans, about 900 senior lab administrators, executives, and pathologists will be gathered at the 28th annual Executive War College on …

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OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens

CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…

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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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March 27, 2023, Intelligence: Late-Breaking Lab News

Clinical laboratory leaders watching at-home care evolve should note the new partnership between Best Buy and Atrium Health in Charlotte, North Carolina. As part of the deal, Best Buy Health, a division of the retailer, will assist patients in setting up the technology pieces of …

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March 6, 2023, Intelligence: Late-Breaking Lab News

Since Congress did not include new regulations for laboratory-developed tests (LDTs) in a year-end spending budget, it appears the Food and Drug Administration (FDA) will take steps of its own to increase the agency’s oversight of LDTs. “We are moving forward with rulemaking,” said Eliza…

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Eight Macro Trends for Clinical Labs in 2023

CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…

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January 3, 2023, Intelligence: Late-Breaking Lab News

At the moment, it appears that the controversial Verifying Accurate Leading-edge IVCT Development (VALID) Act will have a hard time passing in Congress. The bill, which is intended to shift regulation of laboratory-developed tests (LDTs) to the federal Food and Drug Administration…

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