FDA’s Patient Affairs Staff (PAS) in partnership with the National Organization for Rare Disorders (NORD) and Reagan-Udall Foundation for the FDA 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.
Patient-Led Listening Sessions are currently being scheduled for 2021.
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.
Read about the impact Listening Sessions can have on FDA's work:
Learn more about Patient Listening Sessions:
Previously Conducted Listening Sessions
FDA-Requested Listening Session Summaries
- September 11, 2020 - PML session2: Progressive Multifocal Leukoencephalopathy (PML) (PDF - 155KB)
- August 12, 2020 - SMS: Smith-Magenis Syndrome (SMS) (PDF - 143KB)
- July 22, 2020 - PML session1: Progressive Multifocal Leukoencephalopathy (PML) (PDF - 157KB)
- February 4, 2020 - Hunter Syndrome (PDF - 67KB)
- December 2, 2019 - Gastroparesis (PDF - 211KB)
- November 13, 2019 - Childhood Cerebral Adrenal Leukodystrophy (CCALD) (PDF - 222KB)
- October 17, 2019 - Sanfilippo Syndrome - pediatric (PDF - 219KB)
- May 13, 2019 - Sanfilippo Syndrome (PDF - 233KB)
- February 20, 2019 - Celiac Disease (PDF - 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
- November 9, 2020 - Gorlin Syndrome (summary coming soon)
- October 20, 2020 - Limb Girdle Muscular Dystrophies (LGMD)
- October 7, 2020 - Vascular Ehlers-Danlos Syndrome (VEDS)
- September 29, 2020 - Guillain-Barre’ syndrome (GBS)
- September 10, 2020 - Clear Cell Sarcoma (summary coming soon)
- August 3, 2020 - X-Linked Myotubular Myopathy (XLMTM) (summary coming soon)
- July 8, 2020 - Pulmonary Alveolar Proteinosis (summary coming soon)
- June 26, 2020 - Homocystinuria (HCU)
- June 11, 2020 - Von Hippel Lindau (VHL)
- May 5, 2020 - Valosin Containing Protein Disease (VCP)
- March 5, 2020 - Inclusion Body Myositis (IBM)
- January 27, 2020 - Ocular Melanoma
- November 6, 2019 - Cerebral Cavernous Malformation (CCM)
- September 17, 2019 - Osteogenesis Imperfecta (OI)
- August 7, 2019 - Osteoarthritis (OA)
- June 13, 2019 - Neurofibromatosis (NF)
- May 29, 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
Read about the procedures for the management of Patient Listening Sessions by the Patient Affairs Staff in Staff Manual Guide 9006.
Discussions in Patient 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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