Sign up for FDA's Patient Network News2
A twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.
Patient Participation in FDA Regulatory Issues
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 Patient Representative Program Brochure(PDF - 1.2MB) A patient-centered approach (DrugTopics, April 2012)(PDF - 87KB) Patients can serve as checkpoints to guide drug development down the most efficient path.
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.