R. Lewis Dark
Articles by R. Lewis Dark
What’s a Big Headwind for Labs? It’s the LDT Rule!
From the Volume XXXI, No. 10 – July 22, 2024 Issue
Is It Time for Clinical Labs to Embrace Consumers?
From the Volume XXXI, No. 9 – July 1, 2024 Issue
HEALTHCARE IN THIS COUNTRY HAS A WELL-D…
LDT Rule Is Now a Fact! What Will Be Consequences?
From the Volume XXXI, No. 8 – June 10, 2024 Issue
TODAY, THE NEW RULE FOR REGULATION OF LABORATORY DEVELOPED TESTS …
Why Ransomware Attacks Are a Threat to Your Lab
From the Volume XXXI, No. 7 – May 20, 2024 Issue
Have you and your lab management team noticed the major…
Artificial Intelligence and Executive War College
From the Volume XXXI, No. 6 – April 29, 2024 Issue
By the time you read this our 29th annual Executive W…
Are Lab Leaders Ready for Artificial Intelligence?
From the Volume XXXI, No. 5 – April 8, 2024 Issue
WITH ASTONISHING SWIFTNESS, ARTIFICIAL INTELLIGENCE (AI) HAS BECO…
Successful Ransomware Attack Misses Lab Claims
From the Volume XXXI, No. 4 – March 18, 2024 Issue
HAS ANYONE NOTICED THAT CYBERCRIMINALS ARE STEADILY INCREASING THE SCALE AND MAGNITUDE OF THEIR AT…
More Labs Recognize Big Changes Are Coming
From the Volume XXXI, No. 3 – February 26, 2024 Issue
ONE WAY TO DISCERN THE NEAR FUTURE FOR THE CLINICAL LABO…
Read the Tea Leaves… FDA Will Require LDT Review
From the Volume XXXI, No. 2 – February 5, 2024 Issue
PROPOSED FEDERAL REGULATION OF LABORATORY DEVELOPED TESTS (LDTs) IS CURRENTLY THE HOT-BUTT…
FDA Has a Ticking Time Bomb with LDT Rule
PROPOSED REGULATION OF LABORATORY DEVELOPED TESTS (LDTs)…
CURRENT ISSUE
![](https://www.darkintelligencegroup.com/wp-content/uploads/Screenshot-2024-07-24-at-9.42.37 AM.png)
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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