Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
FDA Watch: First Zika Assay Gets Green Light for Marketing
From - Laboratory Industry Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for…
OIG Monthly Work Plan Review: June 2019
From - Lab Compliance Advisor
This month, there were seven new Work Plan items. Two of these, detailed below, may have implications for some labs…
OIG Issues Genetic Testing Fraud Alert
From - National Intelligence Report
On June 3, the OIG issued a fraud alert warning of a genetic testing fraud scheme. According to the OIG, scammers are using…
Multi-Cancer Screening Tests Are Getting Closer to Reality
From - Diagnostic Testing & Emerging Technologies
The hope of developing a single blood test capable of detecting multiple types of early-stage cancer is…