Listening Sessions help FDA understand what is important to patients, caregivers, and patient advocates when medical products are being developed. Patient Affairs Staff (PAS) expects 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 Listening Session, PAS will link to a high level meeting summary on our website. Be sure to check out summaries from previous listening sessions!