Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Researchers Find Marker That May Aid Diagnosis of Erectile Dysfunction
From - Diagnostic Testing & Emerging Technologies
The neutrophil-lymphocyte ratio (NLR) may be a marker to aid in diagnosing erectile dysfunction (ED), according to…
New Project Aims to Provide Legal Guidance Needed to Do Business in Genomics
From - National Intelligence Report
Technology changes faster than the laws designed to regulate it. Thus, while DNA testing has changed medicine and fueled growth in…
FDA Watch: Agency Approves New STD Screening Assay Applications
From - Laboratory Industry Report
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the…
Compliance Perspectives: Use New DOJ Criteria to Vet the Effectiveness of Your Lab Compliance Program
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Case of the Month: Feds Target Doctors Who Took Kickbacks from HDL
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Co-Owner of Kentucky Lab Pleads Guilty to Reference Lab Conspiracy
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Consumers Interested in Raw Genetic Data, Third Party Interpretation Tools
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Search Intensifies for Markers for Prosthetic Joint Infection
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Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready
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