March 15, 2017 – The Food and Drug Administration (FDA) is in talks to create an Office of Patient Affairs to support the agency’s patient engagement efforts and to manage patient input and suggestions.
On March 14, 2017 the FDA published a public docket in the Federal Register soliciting stakeholder feedback for the endeavor. The agency outlined its plans for the Office, stating that it would carry out the FDA’s responsibilities to consult with patients and other patient care experts in medical device and pharmaceutical regulation.
“FDA has long recognized the importance of engaging with patients, caregivers, and their advocates in the medical product development process,” the FDA says.
“Under this proposal to enhance mechanisms for patient engagement at FDA, a new ‘Office of