How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Doctor Pays $228,000 to Settle Urine Drug Test False Billing Charges
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Whistleblower Gets Only Nominal Share in Case Based on Public Information
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Model Illness/Injury Reporting Policy
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Federal Jury Convicts Theranos Founder Elizabeth Holmes of Fraud
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OIG Offers New Advisory Opinion Options—But Should You Use Them?
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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A 16-Step OSHA Recordkeeping Compliance Game Plan
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Current Issue of LCA
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Recent Cases and Enforcement Actions Involving the Diagnostics Industry
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The Year in Lab Compliance: The Biggest Stories of 2021
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