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Unpacking Averages: Assessing FDA's Performance Categorizing New Diagnostic Tests Under CLIA | Epstein Becker & Green

This month’s post focuses on how timely FDA decisions are in categorizing new diagnostics under the Clinical Laboratory Improvements Amendments of 1988 (CLIA). The answer is that, on. ....

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FDA's CLIA Diagnostic Test Performance and Categorization

FDA's CLIA Diagnostic Test Performance and Categorization
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