FDA Holds LDT Workshop Amid Flurry of Debate as Comment Period Nears End

During and surrounding two days of public comment at an FDA-sponsored workshop, various stakeholders sounded off on the LDT regulation debate. As we reported, just prior to the FDA workshop, the American Clinical Laboratory Association issued a white paper with a not-so-veiled threat of litigation (See NIR, 1/8/15, p. 1). Additionally, JAMA published two Viewpoints…