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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
Diagnostic Deals: The Fate of Illumina-PacBio Merger Hangs in the Balance
Will they or won’t they? The suspense continues over whether Illumina’s proposed rescue of Pacific Biosciences will actually close. The $1.2 billion cash merger, which was originally expected to close in mid-2019, is now on indefinite hold due to regulatory antitrust
Compliance Corner: Must Employee Notify Lab of DUI?
QUESTION If one of our employees gets a DUI, do they have to notify us? ANSWER It depends. EXPLANATION There are at least four factors affecting whether the employee would have to come forward and tell you about the DUI? Your HR policies: What, if anything, do your...
Marketing Pitfalls to Avoid: Deceptive Advertising—the Other Kind of “False Claims”
We all know that marketing activity is a breeding ground for potential lab liability. But while most labs are sensitive to the risks posed by the Antikickback Statute, Stark Law and False Claims Act, federal false advertising laws may fly under the radar. Here’s a...