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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
Progress Seen With EGFR Testing, But Adoption Still Lagging
From - Diagnostic Testing & Emerging Technologies
Incomplete implementation of EGFR testing guidelines remains a problem in the realm of non-small cell lung cancer (NSCLC), according to a study published in…
Inside the Lab: Communication, Leadership & Managing Amid Change
From - Laboratory Industry Report
Greek philosopher Heraclitus said the only thing constant is change. Although he never managed a diagnostic lab…
Lab Settles Specimen Collection Fee Kickback Charges for $2.275 Million
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FDA Extends Deadline to Comment on Proposed 510(k) Pathway Reform
From - Lab Compliance Advisor
April 22, 2019 was supposed to the last day to comment on newly proposed FDA guidance on changing the Section 510(k) premarket review process for…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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From Blood Screen to Silver Screen: The Theranos Story Goes Hollywood
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Health Reform: The Latest Twist in the Legal War on Obamacare
From - National Intelligence Report
The Affordable Care Act, aka Obamacare, remains alive but certainly not well. When last we left the melodrama, a federal district court in…
Can a Blood Test Quantify Pain?
From - Diagnostic Testing & Emerging Technologies
A new test could help clinicians objectively measure pain. According to a study published…
OIG Monthly Work Plan Review: March 2019
From - Lab Compliance Advisor
This month, there were 16 new Work Plan items. Three of these may have implications for some labs as…
Compliance Alert: FDA Warning Letter to Inova Genomics Laboratory