Patient Listening Sessions help FDA understand what is important to patients, caregivers, and advocates when medical products are being developed. The Office of Patient Affairs (OPA) expects Patient Listening Sessions (both FDA-requested and patient-led) could serve any of the following objectives:
- Inform regulatory decision-making
- Provide a starting point to inform early stage research & development
- Educate the FDA review staff about health-related experiences, and perspectives, and needs that are most important to patients, caregivers, advocates, and community representatives
- Help patients and advocates understand the FDA’s mission and work
Following a Patient Listening Session, OPA will link to a high level meeting summary on our website. Be sure to check out summaries from previous listening sessions!