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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Debate Continues Over FDA Regulation of LDTs
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Colon Cancer Screening Test Gets FDA Approval, Proposed Medicare Coverage
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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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FDA Official Defends Plan to Issue Guidance for LDTs
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FDA Lowers Risk Classifications For Bone Marrow, Diabetes Diagnostic Tests
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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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FDA to Hold Workshop on LDTs
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Lab Sector Goes to Big Legal Guns in Grapple With FDA Over Test Regulation
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CMS Releases New CLIA-Waived Tests, Billing Codes
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