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
Companion Diagnostics Driving New Model for Pharma-Dx Partnerships
US oncology patients are missing out on targeted therapies due to a combination of testing "quality gaps" and slow test diffusion
FDA Watch: Another First as Agency Approves NGS Oncology Companion Dx for Multiple Therapies
From - Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…
Sequencing-Based Screening Needed for Therapeutic Stem Cells
From - Diagnostic Testing & Emerging Technologies
One of the potential therapeutic advantages of stem cells is that they can regenerate. But, a new study, published May 11 in Nature, suggests that the longer…
Theranos and Walgreens Bury the Hatchet—For Now
From - G2 Compliance Advisor
It all looked so promising back in 2015. Privately-held Theranos was poised to usher in a new era of diagnostics with its revolutionary fingerprick technology for…