BLOGS

FDA

Laboratory Developed Tests (LDTs)

Published by Irving Nachamkin, DrPH, MPH, D(ABMM), FAAM, FIDSA, on December 22, 2015

We need congressional action to modernize CLIA regulations that ensure the quality of Lab Developed Tests (LDTs), rather than having the FDA impose new and unrealistic regulations on top of CLIA requirements.

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