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 Expands Recall of Ellume COVID-19 Home Test Kits
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FDA Targets High Throughput COVID-19 Tests for Recall Due to Risks of False Positives
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FDA Hikes Premarket Application User Fees by 2.5 Percent
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FDA Hikes Premarket Application User Fees by 2.5 Percent
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FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
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FDA Sounds Alarm on Potential Impact of Genetic Mutation on SARS-CoV-2 Molecular Test Accuracy
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FDA Clears the Way for Over-the-Counter Sale of COVID-19 Home Test Kits
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The FDA Drops a Bombshell: No More EUA Review of COVID-19 LDTs
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