Patient Listening Session Summaries
FDA’s Patient Affairs is responsible for managing the Agency’s Patient Listening Session program.
This page contains a list of all the Patient Listening Sessions that have been organized to date. This page is updated frequently with meeting summaries from each Patient Listening Session as they become available.
Patient 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). Only the FDA, patients, caregivers, and advocates participate in the session.
For more information on FDA’s Patient Listening Session program how to request a Patient Listening Session, contact Patient Affairs or click here.
Previously Conducted Patient Listening Sessions
FDA-Requested Patient Listening Session Summaries
- Bronchopulmonary Dysplasia - March 20, 2023
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Carcinoid Syndrome (summary coming soon) – April 27, 2023
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Celiac Disease - February 20, 2019
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Childhood Cerebral Adrenal Leukodystrophy (CCALD) - November 13, 2019
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Fabry Disease - December 4, 2018
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Gastroparesis - December 2, 2019
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Gene Therapy as a Treatment Modality for Hemophilia - October 23, 2018
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Glycogen Storage Disease (GSD) Type 1 – Adult Patients - March 18, 2021
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Glycogen Storage Disease (GSD) Type 1 - Caregivers to Pediatric Patients - March 25, 2021
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Healthcare Challenges and Unmet Medical Needs of Transgender Adults (Session #1) – June 1, 2021
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Healthcare Challenges and Unmet Medical Needs of Transgender Adolescents (Session #2) – June 29, 2021
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Hunter Syndrome - February 4, 2020
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Lupus session 1 - Diversity in Clinical Trials - March 31, 2021
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Lupus session 2 - Diversity in Clinical Trials - April 2, 2021
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Lupus session 3 - Diversity in Clinical Trials - April 6, 2021
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Pouchitis after a total colectomy and ileal pouch anal anastomosis (IPAA) surgery – January 24, 2023
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Progressive Multifocal Leukoencephalopathy (PML) session 1 - July 22, 2020
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Progressive Multifocal Leukoencephalopathy (PML) session 2 - September 11, 2020
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Proteus Syndrome – December 1, 2022
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Síndrome de Proteus - 1 de diciembre de 2022
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Sanfilippo Syndrome - May 13, 2019
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Sanfilippo Syndrome - pediatric - October 17, 2019
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Smith-Magenis Syndrome (SMS) - August 12, 2020
Patient-Led Listening Session Summaries
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Adrenomyeloneuropathy (AMN) External Link Disclaimer - May 7, 202
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Adult Dermatomyositis External Link Disclaimer – April 26, 2022
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Adult Polyglucosan Body Disease External Link Disclaimer – October 28, 2021
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Amyotrophic Lateral Sclerosis (ALS) (summary unavailable) - January 16, 2019
- Biliary Atresia, Progressive Familial Intrahepatic Cholestasis, Wilson's Disease (summary unavailable) - November 5, 2018
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Canavan Disease - March 21, 2023
- C. difficile Infections - March 10, 2023
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Cerebral Cavernous Malformation (CCM) External Link Disclaimer - November 6, 2019
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Clear Cell Sarcoma (summary unavailable) - September 10, 2020
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Congenital Disorders of Glycosylation (CDG) – January 30, 2023
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Cystic Fibrosis – nonsense mutations External Link Disclaimer - July 15, 2021
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Fibrodysplasia Ossificans Progressiva (FOP) External Link Disclaimer - May 29, 2019
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Glycogen Storage Disease (GSD) type 1b External Link Disclaimer - March 3, 2022
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Gorlin Syndrome External Link Disclaimer - November 9, 2020
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Guillain-Barre’ syndrome (GBS) External Link Disclaimer - September 29, 2020
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Homocystinuria (HCU) External Link Disclaimer - June 26, 2020
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Huntington's Disease Pre-Symptomatic Population External Link Disclaimer - July 25, 2022
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Hypomyelination with Atrophy of Basal Ganglia and Cerebellum (H-ABC) External Link Disclaimer - May 9, 2022
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Hypothalamic Obesity External Link Disclaimer – October 22, 2021
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Ichthyosis External Link Disclaimer – September 17, 2021
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Inclusion Body Myositis (IBM) External Link Disclaimer - March 5, 2020
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Juvenile Dermatomyositis (JDM) (summary unavailable) - March 16, 2021
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Juvenile Huntington’s Disease (JHD) – February 10, 2023
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Late Onset GM2 gangliosidoses (Tay-Sachs and Sandhoff diseases) - January 15, 2021
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Leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation (LBSL) (summary coming soon) - May 30, 2023
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Limb Girdle Muscular Dystrophies (LGMD) External Link Disclaimer - October 20, 2020
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Mastocytosis External Link Disclaimer – September 28, 2021
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Narcolepsy and Idiopathic Hypersomnia External Link Disclaimer – August 8, 2022
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Neurofibromatosis (NF) External Link Disclaimer - June 13, 2019
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Neuronopathic Gaucher disease (Types 2 & 3) External Link Disclaimer - September 9, 2021
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Ocular Melanoma External Link Disclaimer - January 27, 2020
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Osteoarthritis (OA) External Link Disclaimer - August 7, 2019
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Osteogenesis Imperfecta (OI) External Link Disclaimer - September 17, 2019
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Pemphigus and Pemphigoid External Link Disclaimer - February 8, 2021
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Post-finasteride Syndrome (PFS) - June 2, 2023
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Pre-Diagnosis Genetic Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Degeneration (FTD) – January 12, 2023
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Primary Ciliary Dyskinesia (PCD) (summary not available) - September 1, 2021
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Pulmonary Alveolar Proteinosis External Link Disclaimer - July 8, 2020
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Pulmonary Sarcoidosis External Link Disclaimer - April 21, 2022
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Recurrent Respiratory Papillomatosis (RRP) - October 27, 2022
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SCN2A Related Disorders External Link Disclaimer - April 28, 2021
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Short Bowel Syndrome External Link Disclaimer - July 19, 2022
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Sickle Cell Disease - May 5, 2023
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Stargardt Disease - June 24, 2022
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Spinal Cord Injury (summary coming soon) – April 24, 2023
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Spinal Muscular Atrophy (SMA) - August 4, 2022
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Thymidine Kinase 2 Deficiency (TK2) External Link Disclaimer – January 31, 2022
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Valosin Containing Protein Disease (VCP) External Link Disclaimer - May 5, 2020
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Vascular Ehlers-Danlos Syndrome (VEDS) External Link Disclaimer - October 7, 2020
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Von Hippel Lindau (VHL) External Link Disclaimer - June 11, 2020
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X-Linked Myotubular Myopathy (XLMTM) (summary unavailable) - August 3, 2020
Learn more about Patient Listening Sessions:
How does FDA benefit from Patient Listening Sessions?
How do I request a Patient Listening Session?
How do I prepare for a Patient Listening Session?
What happens after a Patient Listening Session?
Patient Listening Sessions - Home
Read about the procedures for the management of Patient Listening Sessions by the Office of Patient Affairs 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.
Resources (e.g., funding): It is the patient organization's decision if they are able to plan and hold a Patient 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 Patient 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 Patient Listening Session. All decisions made for the Patient 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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