The Reagan-Udall Foundation for the Food and Drug Administration (the Foundation) is an independent 501(c)(3) organization created by Congress “to advance the mission of the FDA to modernize medical, veterinary, food, food ingredient, and cosmetic product development, accelerate innovation, and enhance product safety.” The Foundation serves as a bridge between the FDA and the public, providing a means for the FDA to interact directly with stakeholders, including industry and consumers, and work together in a transparent way to establish novel, scientific collaborations. Through this collaboration, the Public Engagement Staff and the Foundation are working together on FDA Patient Listening Sessions to enhance FDA’s clinical and regulatory understanding of diseases and conditions and provide a common understanding of the most urgent needs of patients, caregivers and advocates.