A hotly contested proposal by the US Food and Drug Administration to regulate laboratory developed tests (LDTs)—diagnostic tests created and used in-house by hundreds of physicians’ offices, hospitals, and research institutions nationwide—has drawn strong opposition from Sen Lamar Alexander (R, Tennessee), chairman of the Senate Committee on Health, Education, Labor and Pensions (HELP).
Lyon J. Senator Confronts FDA Over Laboratory Tests. JAMA. 2016;316(18):1859. doi:10.1001/jama.2016.16237