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Articles and Reports
LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
ACLA, AHA Submit Comments to CMS Regarding PAMA Final Rules
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Boston Heart Diagnostics Makes Statin Adherence Test More Consumer Friendly
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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…
Sonora Quest Laboratories Enters Into Draw Center Deal With Safeway
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FDA Issues Report Saying Many Laboratory-Developed Tests Are Dangerous
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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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FDA Report Asserts Case Studies Support Need for More Oversight of LDTs
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