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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FDA Watch: Natera, Valar Labs Receive FDA Clearances for Bladder Cancer Tests
Natera’s assay focuses on the need for adjuvant therapy, while Valar’s test stratifies risk of recurrence
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FDA Watch: New RAPID Coverage Pathway Would Enable Some Lab Tests to Pursue Clearance and Medicare Coverage Simultaneously
FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
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Two commercial labs testing now for COVID-19
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CLIA: CMS Issues Guidance on How Labs Should Perform Coronavirus Testing
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Agency to Use EUA Pathway to Clear New Coronavirus Detection Tests
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FDA Targets Sale of IVD Reagents without Premarket Approval
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FDA Resounds the Alarm on Biotin Test Interference
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New Product Development: FDA Issues Final Guidance on IVD Oncology Trials
On Oct. 10, 2019, the FDA finalized guidance on an optional streamlined submission process to determine whether
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LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From – National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
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Inside Washington: What’s Going on with Regulation of LDTs?
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New FDA Guidance Tells IVD Makers How to Test for Biotin Interference
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