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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How to Stay Ahead of Anticipated CLIA Deficiencies
Consultant Nora Hess offers suggestions for clinical labs to navigate these problems
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FDA Updates 2008 Guidance on Categories of Lab Testing
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April Update of CLIA-Waived Tests, Billing Codes
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Joint Commission Clarifies Stance on IQCP
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CMS Divides PT Sanctions Into 3 Categories, Limits Reach of Ban
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Stakeholder Group Calls for Reform of CLIA Waiver Process
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LDT Guidance Unlikely to Be Released Anytime Soon
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FDA Plans to Regulate Lab-Developed Tests Could Increase Time and Cost of Development
In its July 31 notice to Congress, the agency says it would phase in oversight requirements over nine years.
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Lab Execs Air Concerns Over FDA Regulation of LDTs
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Labs Urged to Coordinate With CDC on Ebola Testing
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