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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
HPV DNA from Oral Rinse Samples May Be Prognostic Marker for Head, Neck Cancer
From - Diagnostic Testing & Emerging Technologies
Samples collected from a mouth rinse can detect human papillomavirus (HPV) DNA. These easily collected samples might provide important monitoring information for…
Changes in hazardous waste management: the Generator Improvement Rule
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…
Improved Accuracy of Point-of-Care HbA1c Tests May Expand Access to Testing
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration-cleared POC Afinion HbA1c Dx test (Alere Technologies a subsidiary of Abbott Laboratories) is accurate and…
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
From - National Intelligence Report
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval…
Surviving a Medicare Audit: Warn Lab Staffers Not to Lie to Auditors
From - Lab Compliance Advisor
As a lab compliance director, you understand the dangers of obstructing a Medicare audit. The problem is…
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