FDA Synthesizes Feedback on LDTs in New Discussion Paper

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January 17, 2017

LDTs
FDA Synthesizes Feedback on LDTs in New Discussion Paper
Following up its decision not to issue final guidance in 2016 regarding oversight of laboratory developed tests (LDTs), the U.S. Food and Drug Administration released a…
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HIPAA
First HIPAA Breach Notification Settlement Totals $475,000
Patient health information breaches—whether from hacking, glitches or just plain old carelessness…
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TESTING STRATEGY
Sequencing Following Ultrasound Improves Prenatal Diagnosis
Nonsevere fetal malformations and structural abnormalities are relatively frequent findings of routine, prenatal ultrasounds. Yet, these findings provide…
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EMERGING TESTS
FDA Approves Next-Gen Companion Diagnostic
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine's FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test…
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