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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Democratic Committee Leaders and CMS Present Latest Challenges to Theranos
From - G2 Compliance Advisor
Both the Centers for Medicare & Medicaid Services (CMS) and some high ranking Democratic Committee members had some bad news for…
FDA Approves First Molecular Test of Antibiotic Resistance Directly From Patient Samples
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration (FDA) recently approved the first rapid molecular test for detection of antibiotic resistance directly from…
New FDA Guidances Address NGS and Supporting Variant Databases
From - National Intelligence Report
Promoting flexibility and efficiency, the U.S. Food and Drug Administration (FDA) issued two draft guidances last week addressing oversight of…
Trovagene, University of Michigan Enter Pact to Focus on KRAS-Based Pancreatic Cancer Detection, Treatment
From - Laboratory Industry Report
Trovagene has entered into a pact with the University of Michigan Comprehensive Cancer Center in order to develop a molecular test for the earlier detection and…