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ACLA Files Court Challenge to FDA’s Final LDT Rule

HHS and FDA named as defendants: ACLA and HealthTrackRx are plaintiffs; case filed in Texas

CEO SUMMARY: Discussing the FDA’s final LDT rule, one pathologist tracking this matter wrote, “In many ways, the FDA’s plan [final LDT rule] is like the guy who gets three wishes from a genie, and he asks for unlimited wishes.” ACLA and HealthTrackRx are challenging the FDA’s ...

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ACLA President Van Meter Discusses LDT Lawsuit

Did FDA exceed its statutory authority by issuing its LDT rule? A federal court will now hear this case

CEO SUMMARY: On July 5, the final laboratory developed test (LDT) rule issued by the federal Food and Drug Administration (FDA) takes effect. In response, the American Clinical Laboratory Association (ACLA) filed a lawsuit in federal court in Texas to challenge the FDA’s actions. In thi...

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Attorneys Assess Impact of FDA’s Final LDT Rule

Some lab clients already signaling concerns that compliance costs will end their LDT offerings

CEO SUMMARY: Publication of the Food and Drug Administration’s final rule on laboratory developed tests (LDTs) is already causing some labs to consider withdrawing their existing LDTs because of compliance costs. Two experienced lab industry attorneys discuss aspects of the LDT rule and...

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Several Times, Feds Tried to ‘Redirect’ Lab Activities

During the past five decades, federal regulators attempted several times to recast how labs operated

CEO SUMMARY: Regulation of laboratory developed tests (LDTs) by the Food and Drug Administration (FDA) may turn out to be one of the most impactful federal laws or regulations ever promulgated, so far as it pertains to clinical laboratories.cThe Dark Report provides this historical look b...

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What if Congress Chooses to Pass an LDT-Specific Law?

Despite the FDA’s decision to issue its LDT rule, possibility remains of Congress tackling this subject

CONGRESS HAS YET TO SPEAK SPECIFICALLY ON THE ISSUE of regulating laboratory developed test...

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How Private Health Insurers May Respond to FDA LDT Regulation


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LDT Rule Is Now a Fact! What Will Be Consequences?

TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) issued by the federal Food and Drug Administration ...

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Don’t Be at the Mercy of the Tumultuous Healthcare Revolution

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