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
A Successful FDA cGMP Inspection: The Six Steps of a Pre-Inspection Audit
Performing your own audit to verify compliance and identify problems is one key to achieving a successful FDA audit.
September 2023 Labs in Court
In last month’s key cases, Illumina and Guardant seek to dismiss lawsuit related to trade secrets and breach of contract.
DX Deals: Teaming with Google Leads to WGS Success for PacBio
A strategic partnership with Google enables more accurate whole genome sequencing with machine learning.
September 2023 FDA Watch
More multiplex COVID-19 combination tests emerge from premarket authorization pipeline.
The Top 10 Clinical Lab Acquisitions of 2023
Seven months into the year, there were already four reported deals valued at over $1 billion in 2023, as many as in all of 2022.
Sweeping New FTC Rules Could Chill Healthcare Mergers and Acquisitions
Proposed rule would require businesses to undergo even more stringent review to secure regulatory approval for such deals.
OIG Sheds Light on Kickback Implications of Online Healthcare Directories
Recent advisory opinion offers insight on how healthcare providers may want to structure arrangements involving online directories.
What Are the Latest CFTR Carrier Screening Recommendations?
New ACMG recommendations aim to make CFTR carrier detection more equitable among a wider range of ancestries.
Diagnostic Error: What Harm Can It Do?
Research reveals that diagnostic error in the US may cause up to 800,000 serious outcomes annually.
The Diagnostics Pipeline: FDA Proceeds without Congress Over LDTs Reform
The agency recently sent its own proposed LDTs regulation rule to the White House Office of Information and Regulatory Affairs for review.
