At the NORD Rare Disease and Orphan Drug Breakthrough Summit in Arlington Virginia, we talked with Janet Woodcock, MD, Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) about the increasing role patients have in the development of orphan drugs and how the FDA understands the need for flexibility in designing clinical trial design (while also making sure that it is a trial that properly assesses the drug’s efficacy appropriately). (Source)