Industry Lawyers Float Proposal For Rare Disease Center Of Excellence

Two drug industry lawyers, one of whom sits on the board of a rare disease-focused nonprofit, have drafted a proposal for FDA to create a rare disease center of excellence similar to the agency's Oncology Center of Excellence, which was established in 2017. The Rare Disease COE would help expedite development of medical products to treat rare diseases and provide leadership to FDA's centers on issues of rare disease product development and review. As part of the rare disease initiative,...