Reliable Business Intelligence News About Clinical Laboratories, Pathology Groups, & Laboratory
Diagnostics Since 1995

Top Articles

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 ...

Read More



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...

Read More



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...

Read More



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...

Read More



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...

Read More



How Private Health Insurers May Respond to FDA LDT Regulation

...

Read More



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 ...

Read More


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

Subscribe to The Dark Report for as little as $15.27 per week.

platinum_edition

Get the most expert business intelligence for clinical laboratories and pathology groups available today. Subscribe to The Dark Report.

How Much Laboratory Business Intelligence Have You Missed?

Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!

Sign up for TDR Insider

Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.

;