FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
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Chevron Doctrine’s Dismissal Has Yet to Upend Regulatory Environment
However, clinical laboratories may have more say in future laws and guidance thanks to 2024 decision
FDA Watch: Mass Spectrometry Test Receives First Moderate Complexity Designation
Roche’s vitamin D assay includes internal quality controls that allowed it to obtain the CLIA designation
FDA Warns About Biotin Interference With Lab Tests
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CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency
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Kellison Award goes to FDA’s Dr. Alberto Gutierrez
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
Liquid Biopsies Get FDA Attention
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Congressional Leaders Query FDA and CMS about Theranos
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FDA Guidance Addresses NGS Testing, Espousing Flexibility in Oversight
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