As a requirement of the FDA Safety and Innovation Act, the FDA has begun efforts to improve communication with patient groups in order to improve the FDA’s understanding of patient perspectives and needs in the drug development process. As part of this Patient-Focused Drug Development Initiative, the FDA published a preliminary list of 40 nominated disease areas, including cancer and young patients, that the agency will reduce to 20 disease areas after public comment. Each of the 20 disease areas will receive a public meeting, report, and strategic plan recommending steps to improve the agency’s understanding and consideration of patient needs. In order to encourage the FDA to maintain cancer and young patients as one of the disease areas of focus in this initiative, the Alliance for Childhood Cancer submitted a letter to the agency highlighting the need to better address the needs of childhood cancer patients.
