Rare Disease Report

Biomarkers vs Traditional Outcome Measures - What the FDA Thinks

NOVEMBER 05, 2015
Janet Woodcock, MD

At the NORD Rare Diseases and Orphan Products Breakthrough Summit, we talked with Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA) about the FDA's position on the use of biomarkers in pivotal clinical trials.

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