Patient engagement refers to activities that involve patient stakeholders sharing their experiences, perspectives, needs, and priorities that help inform U.S. Food and Drug Administration (FDA)’s public health mission. Such activities may include (but are not limited to): testimony at Advisory Committee meetings, submission to regulations.gov public docket; meetings attended by patients, FDA, and other stakeholders; other correspondence with FDA; interactions through social media; and interactions with or information from patient representatives or patient advocates.
The goal of patient engagement is to involve the voice of the patient community throughout the therapy development process.
U.S. Food and Drug Administration (FDA) Patient-Focused Drug Development Glossary
Patient-Centered Outcomes Research Institute: Glossary
NCATS Toolkit for Patient-Focused Therapy Development: Empower Your Patient Community Voice