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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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”
Increasing Fees, Decreasing Access to Data in New CMS Proposal
New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research
The Landscape of Laboratory Corruption
How widespread is corruption in the lab—and what can be done to combat it?
The Keys to a Successful Lab Partnership
This webinar will explore the benefits of strategic, deliberate partnerships in order to improve access to quality diagnostic laboratory services, support more timely answers to advance patient care, and serve as a defense mechanism against acquisition
Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Special Report: Will the COVID-19 Recovery Be Bumpier than Expected?
Though IVD and commercial lab Q3 2023 earnings reports held promising signs, Q4 2024 and FY2023 results tell a different story.
Dx Deals: Collaboration Takes Psoriasis Testing to New Level
Partnership between Mindera and PBM aims to optimize treatment matches for the disorder, as some drugs cost nearly six figures annually
FDA Watch: A New Blood Test for Accurate Alzheimer’s Detection
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
Diagnostics Pipeline: FDA Tweaks Quality System Regs to Align with Global Standards
The FDA is adding International Organization for Standardization (ISO) guidelines to its “good manufacturing” requirements
A Primer on PAMA
The impending legislation that may determine Medicare lab fees from 2025 onward
Targeting Group A Streptococcus for System Improvement
This webinar highlights internal processes regarding diagnostics for Group A Streptococcus, and explains how these results benefit patients, providers, and staff