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
Compliance Corner
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LabMD versus the FTC Will Finally Move Forward
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Coming Changes for Clinical Laboratory Fee Schedule May Create New Compliance Risks
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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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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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