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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Additional Business Intelligence Offerings
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”
Keys to a Successful OSHA Annual Review of Your Lab’s Health & Safety Plan
A solid health and safety plan in the lab not only meets regulatory requirements, but also fosters a secure environment for staff
Dx Deals: New Premerger Regulations Could Slow Down Pace of Transactions
The new rules, which were approved by the FTC in October and will go into effect in mid-January, aim to put a damper on consolidation
What to Do in the Event of a Lab Courier Strike
With strikes increasing across industries, what happens if workers involved in the ancillary services labs depend on go on strike?
OSHA Guidance for Labs: 2024 and Beyond
Safety and health guidance for labs—including recent updates, forthcoming changes, and how lab professionals can stay up to date
Generalizing Genomics Learning
A new NIH network aims to remove barriers and share knowledge to drive more widespread adoption of genomics in clinical settings
Diagnostics Pipeline: Testing for Intestinal Parasites Takes Step Forward
The EasyScreen assay received 510(k) clearance from the Food and Drug Administration earlier this year–but with a catch
AI in Genomics: The Next Generation
How artificial intelligence and machine learning tools stand to benefit clinical labs throughout the genomics pathway
Evolving Regulations and Guidelines in Genetic Testing
Understanding the regulatory landscape of genetic and genomic testing, and its impact on clinical practice
When Is Genome Sequencing Advisable?
With patient and provider demand for WGS on the rise, what should laboratorians know about ordering and interpreting this testing?
Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule