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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Articles and Reports
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
News at a Glance – May 2016
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DOJ Continues Focus on Individual Accountability with FCPA Self-Disclosure Pilot
From - G2 Compliance Advisor
If the Foreign Corrupt Practices Act (FCPA) sounds like it shouldn't be of concern to laboratories and the diagnostics industry, think again. Alere, a point-of-care diagnostic test maker, recently disclosed…
Convictions, Sentences and a Costly Settlement in Recent Lab Test Enforcement Cases
From - G2 Compliance Advisor
In just this month, lab anti-kickback and false claims enforcement cases have led to the conviction of two lab professionals, prison sentences for a physician and for…
Avoid False Claims Liability: CMS Clarifies How to Comply with 60-Day Deadline for Returning Medicare Overpayments
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FDA’s LDT Oversight Framework Could Impact 60,000+ Tests
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Make Sure Existing Compliance Policies Match Current Operations
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News at a Glance
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