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
Recent Case Highlights Importance of Where Whistleblowers Get Info
What happens when a whistleblower’s case is based on information that’s already been publicly disclosed?
FDA Resumes Domestic Surveillance Inspections but Faces Huge Backlogs
They’re baaaack! FDA surveillance inspectors returned to the beat on Monday, at least for domestic operations. On Dec. 31, the agency announced a temporary freeze on all but “mission-critical” inspections to protect inspectors from Omicron. The freeze, the second...
Three Key Changes Your Lab Staff Need to Know About
CMS recently announced some important changes affecting PAMA price reporting, along with a list of 17 new PLA codes that will be recognized.
Don’t Use These Rapid COVID-19 Tests, FDA Warns
The US Food and Drug Administration recently issued a letter warning people not to use two different tests produced by Empowered Diagnostics.
Feds False Claim Recoveries Top $5.6 Billion
The cost of recoveries hit an eight-year high in FY 2021, with the health care industry footing 90 percent of the bill.