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FDA Law Blog
FDA Issues Memo to Reclassify Many High Risk IVD Assays
WAS IT AN EXPECTED FLOOD OF APPLICATIONS TO REVIEW laboratory de…
CURRENT ISSUE
Volume XXXI, No. 14 – October 14, 2024
For the second time in the past 16 months, respected health systems have taken steps to collaborate specifically to advance value-based care. Also, several statewide pilot programs—each involving tens of thousands of newborns—are publishing studies that demonstrate how exome, whole genome sequencing, and rapid whole genome sequencing can deliver both improved patient outcomes and a return on investment.
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