Patient Engagement in the FDA Process

On June 6, 2015, FDA released draft guidance on Duchenne Muscular Dystrophy. This draft guidance was significant because it was proposed and drafted by the Parent Project Muscular Dystrophy (PPMD) then given to the Food and Drug Administration (FDA) to consider. PPMD was eager to work with FDA toward a drug development guidance, and their success marks the first patient-FDA relationship of its kind. Can this process be replicated by other patient organizations as they fight to develop their own guidance for development? During this webinar, PPMD’s President and CEO, Pat Furlong, and FDA Center for Drug Evaluation and Research Director, Janet Woodcock, will discuss their experience in working toward this draft guidance. Debra Lappin, principal in FaegreBD Consulting's health and biosciences team, will moderate.