Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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- 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”
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
Diagnostic Deals: A Roundup of the Key Mergers, Acquisitions, Alliances, Licenses and Other Strategic Transactions From the Past Month
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Improved Accuracy of Point-of-Care HbA1c Tests May Expand Access to Testing
From - Diagnostic Testing & Emerging Technologies
The U.S. Food and Drug Administration-cleared POC Afinion HbA1c Dx test (Alere Technologies a subsidiary of Abbott Laboratories) is accurate and…
Case of the Month: FDA Issues Warning Letter for Unapproved Changes to Approved Assay
From - National Intelligence Report
As a rule of thumb, FDA approvals are a snapshot applicable only to the product as it exists at the time of review and approval…
Surviving a Medicare Audit: Warn Lab Staffers Not to Lie to Auditors
From - Lab Compliance Advisor
As a lab compliance director, you understand the dangers of obstructing a Medicare audit. The problem is…
PacBio Settles Lawsuits with Shareholders Over Illumina Acquisition
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Case of the Month: U.S. Supreme Court Gives Whistleblowers Four More Years to Sue
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OIG Monthly Work Plan Review: May 2019
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Rapid, Genomic-Based Surveillance IDs Aids Hospital Infection Control
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