Thank you for your interest in requesting a Patient Listening Session!
Please read all of the information in the sections below before submitting your request. If you are unsure if a Patient Listening Session is the best way to talk to FDA, the Office of Patient Affairs can help! Contact us through the Patients Ask FDA webform, by email at PatientAffairs@fda.gov or by phone at 301-796-8460.
Patient Listening Sessions are one of many ways patients, caregivers, and their advocates can share their experiences and perspectives by talking directly with FDA staff.
- Patient Listening Sessions are small, informal, non-regulatory, non-public discussions
- Patient Listening Sessions are scheduled for up to 1.5 hours and can be in person at FDA in Silver Spring, MD, on the phone, or a mix of the two
- Patient Listening Sessions are about your health-related experiences and perspectives, not a specific medical product (drug, biologic, or device)
Only the FDA, patients, caregivers, advocates, and community representatives participate in the Patient Listening Session. For some sessions, FDA's Office of Patient Affairs works in partnership with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation for the FDA. FDA staff will listen to better understand your experiences and perspectives and may ask questions to learn more.
Patient Listening Sessions help FDA understand what is important to you and your patient and advocacy community when medical products are being developed.
The Office of Patient Affairs will work with you to see if a Patient Listening Session is the best way to talk with FDA. Patient Listening Sessions:
- Are small, informal, non-regulatory, non-public teleconference meetings
- Allow participants to share their experiences and perspectives with FDA staff first-hand
- About patient experiences, perspectives, and needs related to their health or a disease, and not about specific medical products (drug, biologic, or device)
- An opportunity for the FDA to connect with under-represented communities
- Help the FDA better understand what is most important to different communities and individuals who have specific health, medical, and treatment needs
- Of interest to medical product center staff in multiple FDA Centers/programs
- Not on the same set of agenda topics as a past meeting held or future meeting planned with FDA
SUBJECT/TOPIC OF PATIENT LISTENING SESSION
List the subject(s) that you plan to discuss with the FDA. Describe the patient population along with health condition, disease or your specific concern.
DESIRED MEETING GOALS
Describe why you want to meet with FDA. Describe what you hope FDA will learn. Describe what you hope to gain from a Patient Listening Session.
PATIENT LISTENING SESSION TOPICS
Describe the topics you would like to cover in this Patient Listening Session about the patient’s experience.
PROPOSED DRAFT MEETING AGENDA
Example: Draft Agenda
- FDA Opening Remarks (3 min) - Patient Affairs
- Disease Overview (5-10 min)
- Patient/Caregiver Testimonials (30-60 min) - 5 to 7 speakers
- FDA Open Discussion (10-15 min) - Patient Affairs
- FDA Closing Remarks (2 min) - Patient Affairs.
Follow these steps to start your request for a Patient Listening Session:
1. Go to www.fda.gov/PatientsAskFDA
2. Complete the form
3. Under the section about the FDA Programs, click: “Patient Listening Sessions” In remaining boxes on the form, enter the information from the section above including:
- the health condition, disease or your specific concern;
- what you would like to share during the patient listening session;
- a draft meeting agenda; and
- what you hope to happen after the patient listening session
4. Click “Submit”
We will review the request for completeness, evaluate the request, and follow up with you. In the meantime, check out summaries from previous patient listening sessions!