FDA is considering establishing an Office of Patient Affairs, which would coordinate patient engagement activities across the agency's medical product centers and offices. FDA said the plan was inspired by stakeholder comments it received in a 2014 docket addressing patient participation in medical product discussions.
In a Federal Register notice, FDA said the proposed office would offer a single entry point for the patient community and assist stakeholders with inquiries. It plans to develop online channels for patient communication, and provide data management systems that incorporate knowledge that patient stakeholders have shared with FDA. Comments are due on June 12th,