“Rare diseases are not a rare problem. Over 30 million Americans live with a rare disease but most have no FDA-approved treatment available. Too often, applications for new and innovative products for ultra-rare diseases get bogged down or lost due to misunderstanding or needless red tape. The new Rare Disease Innovation Hub is a welcome step forward to provide a more transparent process for applicants by consistently incorporating expertise and best practices across the agency as well as the experience of patients living with rare diseases.”