CMS Proposes to Modernize CLIA in Broad Rule
What clinical labs need to know about virtual access, director qualifications, and more
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FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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After Nearly 3 Decades, CMS Proposes Updates to Proficiency Testing Rules
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Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From – G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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Theranos Faces New Challenges and Increasing Federal Scrutiny
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CMS Issues Deficiency Letter to Theranos
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FDA’s 2016 Guidance Plans Include LDTs and Other Diagnostics Topics
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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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AMP Offers Proposal for Regulation of Laboratory Developed Tests
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Outcome of LDT Regulation Controversy Defies Forecasting
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