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
Surviving a Cyberattack
When it comes to cyberattacks, the threat is “when,” not “if”—and labs must be prepared to mitigate, contain, and recover from breaches
Special Analysis: Addressing Key Concerns Around the FDA’s Final LDTs Rule
Experts answer key questions related to laboratory-developed test regulation during G2 Intelligence webinar.
Dx Deals: Quest Closes PathAI Partial Acquisition and Strategic Alliance
Deal is expected to give the lab giant a big boost in deploying artificial intelligence in the pathology space.
How to Prevent the Top 10 CLIA Deficiencies
A laboratory safety expert shares the most common CLIA citations from recent lab inspections, and how your lab can avoid similar problems.
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
