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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Lab Industry Advisor Subscriptions Include
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
ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Diagnostics Pipeline: Startup Women’s Health Lab Receives $4M in Federal Grants
The grants, which include $3 million from the NIH and $1 million from the NSF, will help the company develop point-of-care tests
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
Getting Started with the FDA’s New LDT Rule
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
10 Top CLIA Deficiencies for Labs and How to Avoid Them
Areas to address when preparing for your next CLIA inspection, based on recent data on top CLIA deficiencies
What the FTC’s New Noncompete Rule Means for Your Lab
The new rule, which goes into effect September 4, will ban noncompete agreements for most workers, including those in the lab industry.
Perfect Partners: Healthcare Quality and the Clinical Lab
How labs form an indispensable part of the CMS National Quality Strategy, helping to drive healthcare improvements and scientific growth.
July 2024 Labs in Court
Genetic testing related fraud was a theme in recent enforcement actions involving medical laboratories and lab testing
Becoming Proficient in Proficiency Testing
Quality expert Sten Westgard discusses the latest CLIA update: “It’s time to have performance goals built in this century”