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
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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
National Academies’ Report Offers Hope for Scrapping Proposed Changes to Research Regulations
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CMS Report to Congress Cites Program Integrity for $42 Billion in Savings, $12.40 ROI
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Lab and Pathology Industry Responds to Proposed MACRA Rules
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FDA Issues Draft Guidelines for Companion Diagnostics
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FDA Seeks Public Comment on Blood Donor Deferral Policy to Decrease HIV Transmission
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FDA Approves Rapid Molecular Diagnostic Test for Detecting Antibiotic Resistance
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Corporate Venture Capital Ups Investments in Health Deals
From - Diagnostic Testing & Emerging Technologies
Health care corporate venture capital (CVC) is increasing across all sectors of the industry in terms of number of deals, dollars invested, and number of…
Program Integrity Saves Medicare $42 Billion
From - National Intelligence Report
In a new report to Congress, the Centers for Medicare & Medicaid Services reports the Program Integrity activities have saved Medicare and…
Quest Reports Higher Quarterly Profit, But Revenue Is Flat
From - Laboratory Industry Report
Quest Diagnostics reported flat revenue growth but robust profits for the second quarter of…
Theranos Adds Compliance Focused Executives and Board Committee
From - G2 Compliance Advisor
While still facing serious sanctions from CMS, Theranos has been taking steps to rehabilitate its compliance image. The company announced the appointment of…