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Sen. Alexander Wants To ‘Start From Scratch’ In Regulating Lab-Developed Tests

Executive Summary

Senate HELP Committee Chair Lamar Alexander, R-Tenn., suggested he would prefer to “start from scratch” in developing appropriate regulatory controls for laboratory-developed tests, despite a proposed regulatory framework for US FDA for the tests that was more than a decade in the making. That triggered some debate at a Sept. 20 committee hearing.

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