Patient Listening Sessions help FDA understand what is important to patients, caregivers, and patient 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 review staff about rare diseases or specific segments of non-rare diseases
- Help patients and their 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!