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
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
FDA Watch: Agency Issues New Guidance to Ease Approval of NGS Tests & IVD Devices
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…
PAMA Reimbursement: CMS Tells Labs How to Secure ADLT Status for New Tests
From - G2 Compliance Advisor
Although the 2018 market-based Clinical Laboratory Fee Schedule (CLFS) is officially in effect, implementation of the new…
Emerging Tests: Medicare to Cover Next Gen-Sequencing Tests for Advanced Cancer
From - National Intelligence Report
In the PAMA era, there are two salient trends in Medicare Part B lab reimbursements…