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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FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
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More FDA Workshops Focus on NGS Technology
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FDA Looks Back at Successes and Details Plans for 2016, Including LDTs
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FDA Report Asserts Case Studies Support Need for More Oversight of LDTs
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Two FDA Workshops Focus on Precision Medicine Issues
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AMP Offers Proposal for Regulation of Laboratory-Developed Tests
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