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Under New Leadership, FDA Diagnostics Office To Tighten Its Control

This article was originally published in The Gray Sheet

Executive Summary

Taking its cue from the new, more aggressive FDA administration, the agency's diagnostics office aims to tighten its regulatory control over commercial tests and, potentially, lab-developed assays, according to the new director of the Office of In Vitro Diagnostic Device Evaluation and Safety, Alberto Gutierrez
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