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Why Labs Should Comply with FDA’s Final Rule on LDTs
By Robert Michel | From the Volume XXXII, No. 3 – February 17, 2025 Issue
CEO SUMMARY: Even as lawsuits challenging the Laboratory Developed Test (LDT rule) issued by the federal Food and Drug Administration (FDA) progress in federal court, clinical labs performing LDTs face an interesting decision. Should they invest the staff time and money to comply with the…
No Surprises Act Sparks a Slew of Court Decisions
By Scott Wallask | From the Volume XXX, No. 13 – September 11, 2023 Issue
CEO SUMMARY: Multiple lawsuits filed by the Texas Medical Association against the federal government have resulted in key decisions that affect provisions in the law. Qualifying payment amounts and …
Big Employers Sue Payers over Price Transparency
By Robert Michel | From the Volume XXX, No. 12 – August 21, 2023 Issue
CEO SUMMARY: Feeling they’ve been denied access by insurance companies to price data about medical claim payments, self-funded employer plans and unions are taking their health insurance companies…
Judge Vacates Provision in No Surprises Act
By Robert Michel | From the Volume XXIX, No. 5 – April 4, 2022 Issue
CEO SUMMARY: It …
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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