Thank you for your interest in requesting a Patient Listening Session! The information on this page is also available as a 2-page PDF that can be downloaded or printed.
Please read all of the information in the sections below before submitting your request. If you are unsure if a Listening Session is the best way to talk to FDA, Patient Affairs Staff can help! Contact us through the Request to Connect webform, by email at PatientAffairs@fda.gov or by phone at 301-796-8460.
Patient-Led Listening Sessions are currently being scheduled for 2021.
- Listening Sessions are small, informal, non-regulatory, non-public discussions
- 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
- Listening Sessions are about your rare disease experiences, not a specific medical product (drug, biologic, or device)
Only the FDA, patients, caregivers, and advocates participate in the Listening Session. FDA staff will listen to better understand your experience with a disease or condition and may ask questions to learn more.
Listening Sessions help FDA understand what is important to you and your patient community when medical products are being developed.
The Patient Affairs Staff (PAS) will work with you to see if a Listening Session is the best way to talk with FDA. Some criteria for Listening Sessions include:
- Rare disease area, defined as a condition affecting fewer than 200,000 patients in the U.S.
- Of interest to medical product 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
DISEASE OR CONDITION NAME
List the disease or condition that you plan to discuss with FDA.
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 Listening Session.
LISTENING SESSION TOPICS
Describe the topics you would like to cover in this Listening Session about the patient’s experience living with a disease or condition.
PROPOSED DRAFT MEETING PLAN
Create a draft meeting plan for a 1.5-hour listening session. Please allow 5 minutes for FDA opening remarks and 15 minutes at the end for open discussion between FDA and the patient community. Indicate if you prefer the session to be in person, by teleconference, or both.
Follow these steps to start your request for a Listening Session:
- Go to www.fda.gov/requesttoconnect
- Complete the form
- Under the section about the FDA Programs, click: “Listening Sessions”
- In remaining boxes on the form, enter the information from the section above including the name of the disease or condition, what you would like to share during the Listening Session, and what you hope to happen after the listening session
- 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 listening sessions!