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Medical Device

IOM On “Omics” Assays: Stricter Controls Are Needed For Development Process

This article was originally published in The Gray Sheet

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Executive Summary

The Institute of Medicine recommends a highly controlled, step-wise approach to bringing complex genomic, proteomic and similar assays from basic research to clinical testing. FDA needs to play a central role, IOM stresses in a recent report.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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