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
Evaluate, increase your lab’s compliance budget
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Could Pharmasan Settlement Be Harbinger for More Corporate Admissions of Wrongdoing?
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FDA Workshop Addresses Security of Medical Devices
From - G2 Compliance Advisor
The U.S. Food and Drug Administration (FDA) is joining the cadre of government agencies calling attention to the cybersecurity risks of wireless, internet-and network-connected devices and…
AABB and A2LA Form Laboratory Accreditation Partnership
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Make Sure Your PPE Matches the Hazard
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Yates Memo Creates Additional Compliance Risk for Labs and Their Executives
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Congress Asks CMS to Delay PAMA Implementation
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OIG Releases 2016 Work Plan, Again Targeting Laboratory Billing
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Re-evaluate and Update Your Compliance Plans
From - G2 Compliance Advisor
The Department of Justice (DOJ) and the U.S. Department of Health and Human Services' Office of Inspector General (OIG) have been very active in fraud prevention and enforcement, recovering $3.3 billion in taxpayer dollars in…
HCCA Releases Compliance Officer/Staff Compensation Data
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