FDA’s Patient Affairs Staff (PAS) in partnership with the National Organization for Rare Disorders (NORD) is excited to host Patient Listening Sessions! Patient Listening Sessions are a resource for the medical product Centers to quickly engage with patients or their advocates and are one of many ways the patient community can share their experience with a disease or condition by talking directly with FDA staff.
What are Listening Sessions?
Listening Sessions can either be FDA-requested (where FDA has a specific set of questions to ask) or patient-led (when a patient community wants to share their perspectives with the FDA). Listening Sessions are:
- Small, informal, non-regulatory, non-public discussions
- About disease experiences, not a specific medical product (drug, biologic, or device)
- 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
During a Listening Session, FDA staff will either ask questions or simply listen to better understand your experience with a disease or condition. Only the FDA, patients, caregivers, and advocates participate in the session.
Learn more about Patient Listening Sessions:
Patient-Led Listening Sessions are currently being scheduled in 2020.
Previously Conducted Listening Sessions
FDA-Requested Listening Session Summaries
- May 13, 2019 - Sanfilippo Syndrome (summary coming soon)
- February 20, 2019 - Celiac Disease (PFD-200KB)
- December 4, 2018 – Fabry Disease (PDF - 171KB)
- October 23, 2018 – Gene Therapy as a Treatment Modality for Hemophilia (PDF- 205KB)
Patient-Led Listening Session Summaries
- August 7th, 2019 - Osteoarthritis (OA) (summary coming soon)
- June 13th, 2019 - Neurofibromatosis (NF) (summary coming soon)
- May 29th, 2019 - Fibrodysplasia Ossificans Progressiva (FOP)
- January 16, 2019 - Amyotrophic Lateral Sclerosis (ALS) (summary unavailable)
- November 5, 2018 - Biliary Atresia, Progressive Familial Intrahepatic Cholestasis, Wilson's Disease
Discussions in FDA Rare Disease Listening Sessions are informal. All opinions, recommendations, and proposals are unofficial and nonbinding on FDA and all other participants. FDA does not cover the travel expenses of participants coming to campus.
Resources (e.g., funding): It is the patient organization's decision if they are able to plan and hold a Listening Session for their community. Planning can be done with minimum expense to the organization (e.g., FDA does not encourage using event planners, consultants, scientific writers, or other external resources on your team, especially when resources (e.g., funding) may be limited). For transparency, the patient organization should identify any financial sponsors and any subsequent Listening Session materials. The patient organization and other planning team members and collaborators are also encouraged to share any interactions (financial and non-financial) that may be related to planning and conduct of the Listening Session. All decisions made for the Listening Session (e.g., development of agenda, discussion, selection of patient participants) should only be done by the patient organization. Input from medical product sponsors is not encouraged.
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