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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How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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Four Federal Efforts to Monitor, Including RESULTS Act Progress
Other proposals aim to increase fraud enforcement, temper prior authorization, and modernize CLIA
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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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Don’t Overlook Free Resources When Preparing Your Laboratory for ICD-10
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