Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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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
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
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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