FDA Watch: Lab Industry Objects to Agency's New LDT Proposal

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September 11, 2018  
placeholder  NEW PRODUCTS
FDA Watch: Lab Industry Objects to Agency's New LDT Proposal
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
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placeholder  COMPLIANCE PLANS
OIG Monthly Work Plan Review: August 2018
From - G2 Compliance Advisor
Of the 12 new Work Plan items, four have direct implications for labs and billing of lab tests…
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placeholder  TESTING STRATEGY
Hidden Blood in Stool May Indicate Higher All-Cause Death Risk
From - Diagnostic Testing & Emerging Technologies
"Invisible" blood in stool may predict death from a wide range of causes, not just colorectal cancer, according to a study published July 16 in…
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placeholder  LAB SAFETY
The Safety Interpretation
From - National Intelligence Report
When hospitals were placed on OSHA's list of "high-risk" workplaces, no one had to ask why. OSHA adjusts that list based on the number of injuries that occur on the job…
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