TAG:
Department of Defense
What Labs with LDTs Must Do to Comply with FDA’s LDT Rule
CEO SUMMARY: Until the recently filed court challenge to the Food and Drug Administration’s LDT rule succeeds or Congress intervenes with new legislation, those clinical laboratories performing laboratory developed tests (LDTs) must comply with the requirements of the new rule. This com…
FDA Hosts Webinar to Explain Key Issues with Final LDT Rule
ON APRIL 29. THE US FOOD AND DRUG ADMINISTRATION (FDA) announc…
Lab’s Innovation Center Encourages Staff Ideas
CEO SUMMARY: At a time when health plans consider lab testing a commodity, the team at Sonora Quest Laboratories deliberately set out to encourage ideas and innovation from its staff by creating the “Innovation Center of Excellence.” One innovation involves helping health plans and ph…
July 6, 2021 Intelligence: Late-Breaking Lab News
Did the SARS-CoV-2 virus infect people in the United States earlier than the first case diagnosed on Jan. 19, 2020? A newly-published study in Clinical Infectious Diseases, says there is evidence of COVID-19 infections in December 2019. The research team included scientists from the Nationa…
CURRENT ISSUE
Volume XXXI, No. 10 – July 22, 2024
An attorney widely experienced in clinical laboratory regulation has prepared guidelines for complying with the FDA’s new LDT rule, and The Dark Report offers them in their entirety to readers. Also, a House of Representatives bill includes language calling for the FDA to suspend its rule.
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