For Consumers

Patient Involvement

Patient Representative Program
The Patient Representative is responsible for providing the Food and Drug Administration (FDA) and the advisory committee the unique perspective of patients and family members directly affected by a serious or life-threatening disease.
Drug Development Patient Consultant Program
This program incorporates the perspective of patient advocates into the drug development process allowing them an opportunity to participate in the FDA drug review regulatory process.
Patient Representatives to FDA Advisory Committees
Frequently Asked Questions for Patient Representatives
Guidelines for Speakers at the Open Public Hearing of an FDA Advisory Committee Meeting
The Value of Patient's Perspective
in the FDA Decision Process, Sharon Smith Holston, Deputy Commissioner, FDA, 10th IMS International Symposium, November 3, 1997
Patient Representative Program Brochure (PDF - 1282KB)

FDA 101: Advisory Committees
Advisory Committees: FDA's Primary Stakeholders Have a Say
The history and role of consumer and patient representatives on FDA Advisory Committees.
Bringing Real Life to the Table: Patient Reps Help FDA Review Products
Representing the patient's perspective in FDA Advisory Committee meeting.