New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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Legal Dispute Highlights Contract Terms that Also Raise Compliance Issues
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Compliance Corner
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LabMD versus the FTC Will Finally Move Forward
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Serial Relator Ends up Paying Attorney Fees
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Allergy Lab Owner Gets Prison Time for Faking Test Results
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Effective Compliance Program Could Have Thwarted Rogue Employees
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Legal Dispute Highlights Contract Terms that Also Raise Compliance Issues
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LIR Current
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LCA Current
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