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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
Hologic Turns COVID-19 Testing Cash into Strategic Acquisitions in Core Women’s Health Space
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FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
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How the Transition from Trump to Biden Will Affect Federal Regulation and Reimbursement
“Meet the new boss. . . same as the old boss.” The Who’s “Won’t Get Fooled Again” is a rock classic; but as far as U.S. presidents and federal regulation are concerned, the “new boss” is almost never the same as the “old boss.” The typical pattern: The outgoing...
Mergers, Acquisitions & Asset Sales Analysis – February 2021
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Strategic Alliances, Partnerships & Collaborations Analysis – February 2021
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The power of the pause for avoiding injury
By Dan Scungio bio The majority of laboratory injuries and exposures are preventable, and most of them occur because people are not paying close attention to the situation. They lose their situational awareness or were never paying attention to it from the start....