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.
Attention-Deficit/Hyperactivity Disorder (ADHD) – March 15, 22, and 29, 2024
Carcinoid Syndrome – April 27, 2023
Celiac Disease – February 20, 2019
Childhood Cerebral Adrenal Leukodystrophy (CCALD) – November 13, 2019
Congenital Cytomegalovirus Infection (cCMV) – April 4, 2024
Fabry Disease – December 4, 2018
Gastroparesis – December 2, 2019
Gene Therapy as a Treatment Modality for Hemophilia – October 23, 2018
Glycogen Storage Disease (GSD) Type 1 – Adult Patients – March 18, 2021
Glycogen Storage Disease (GSD) Type 1 – Caregivers to Pediatric Patients – March 25, 2021
Healthcare Challenges and Unmet Medical Needs of Transgender Adults (Session #1) – June 1, 2021
Healthcare Challenges and Unmet Medical Needs of Transgender Adolescents (Session #2) – June 29, 2021
Hunter Syndrome – February 4, 2020
Lupus session 1 – Diversity in Clinical Trials – March 31, 2021
Lupus session 2 – Diversity in Clinical Trials – April 2, 2021
Lupus session 3 – Diversity in Clinical Trials – April 6, 2021
Pouchitis after a total colectomy and ileal pouch anal anastomosis (IPAA) surgery – January 24, 2023
Progressive Multifocal Leukoencephalopathy (PML) session 1 – July 22, 2020
Progressive Multifocal Leukoencephalopathy (PML) session 2 – September 11, 2020
Proteus Syndrome – December 1, 2022
Síndrome de Proteus – 1 de diciembre de 2022
Sanfilippo Syndrome – May 13, 2019
Sanfilippo Syndrome – pediatric – October 17, 2019
Smith-Magenis Syndrome (SMS) – August 12, 2020
Adrenomyeloneuropathy (AMN) External Link Disclaimer – May 7, 2021
Adult Dermatomyositis External Link Disclaimer – April 26, 2022
Adult-onset leukoencephalopathy with axonal spheroids and pigmented glia (ALSP) – January 17, 2024
Adult Polyglucosan Body Disease External Link Disclaimer – October 28, 2021
Amyotrophic Lateral Sclerosis (ALS) (summary unavailable) – January 16, 2019
Atypical Hemolytic Uremic Syndrome (aHUS) – September 21, 2023
Canavan Disease External Link Disclaimer– March 21, 2023
Cerebral Cavernous Malformation (CCM) External Link Disclaimer – November 6, 2019
Clear Cell Sarcoma (summary unavailable) – September 10, 2020
Congenital Disorders of Glycosylation (CDG) External Link Disclaimer– January 30, 2023
Cystic Fibrosis – nonsense mutations External Link Disclaimer – July 15, 2021
DLG4-related synaptopathy (summary coming soon) – July 17, 2024
Facioscapulohumeral muscular dystrophy (FSHD) (summary coming soon) – August 23, 2024
Fibrodysplasia Ossificans Progressiva (FOP) External Link Disclaimer – May 29, 2019
Glycogen Storage Disease (GSD) type 1b External Link Disclaimer – March 3, 2022
Gorlin Syndrome External Link Disclaimer – November 9, 2020
Guillain-Barre’ syndrome (GBS) External Link Disclaimer – September 29, 2020
Homocystinuria (HCU) External Link Disclaimer – June 26, 2020
Huntington’s Disease Pre-Symptomatic Population External Link Disclaimer – July 25, 2022
Hypomyelination with Atrophy of Basal Ganglia and Cerebellum (H-ABC) External Link Disclaimer – May 9, 2022
Hypothalamic Obesity External Link Disclaimer – October 22, 2021
Ichthyosis External Link Disclaimer – September 17, 2021
Inclusion Body Myositis (IBM) External Link Disclaimer – March 5, 2020
Juvenile Dermatomyositis (JDM) (summary unavailable) – March 16, 2021
Juvenile Huntington’s Disease (JHD) External Link Disclaimer– February 10, 2023
KCNT1-Related Epilepsy External Link Disclaimer – April 22, 2024
Late Onset GM2 gangliosidoses (Tay-Sachs and Sandhoff diseases) – January 15, 2021
Leber congenital amaurosis (LCA) (summary not available) – October 30, 2023
Leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation (LBSL) (summary not available) – May 30, 2023
Limb Girdle Muscular Dystrophies (LGMD) External Link Disclaimer – October 20, 2020
Mastocytosis External Link Disclaimer – September 28, 2021
MEF2C Haploinsufficiency Syndrome (MCHS) (summary coming soon) – September 19, 2024
Narcolepsy and Idiopathic Hypersomnia External Link Disclaimer – August 8, 2022
Neurofibromatosis (NF) External Link Disclaimer – June 13, 2019
Neurofibromatosis Type 1 (NF1)/Cutaneous Neurofibroma (cNF) – May 21, 2024
Neuronopathic Gaucher disease (Types 2 & 3) External Link Disclaimer – September 9, 2021
Non-ketotic Hyperglycinemia (NKH) (summary coming soon) – December 15, 2023
Ocular Melanoma External Link Disclaimer – January 27, 2020
Okur-Chung neurodevelopmental syndrome (OCNDS) (summary coming soon) – July 23, 2024
Osteoarthritis (OA) External Link Disclaimer – August 7, 2019
Osteogenesis Imperfecta (OI) External Link Disclaimer – September 17, 2019
Pelizaeus Merzbacher Disease (PMD) External Link Disclaimer – August 22, 2023
Pemphigus and Pemphigoid External Link Disclaimer – February 8, 2021
Post-finasteride Syndrome (PFS) – June 2, 2023
Post-Traumatic Stress Disorder (PTSD) (summary coming soon) – August 13, 2024
Pre-Diagnosis Genetic Amyotrophic Lateral Sclerosis (ALS) and Frontotemporal Degeneration (FTD) External Link Disclaimer – January 12, 2023
Primary Ciliary Dyskinesia (PCD) (summary not available) – September 1, 2021
Pulmonary Alveolar Proteinosis External Link Disclaimer – July 8, 2020
Pulmonary Sarcoidosis External Link Disclaimer – April 21, 2022
Pyruvate Dehydrogenase Complex Deficiency (PDCD) External Link Disclaimer– September 8, 2023
Recurrent Respiratory Papillomatosis (RRP) External Link Disclaimer– October 27, 2022
SCN2A Related Disorders External Link Disclaimer – April 28, 2021
Short Bowel Syndrome External Link Disclaimer – July 19, 2022
Sickle Cell Disease – May 5, 2023
Stargardt Disease – June 24, 2022
Spinal Cord Injury External Link Disclaimer– April 24, 2023
Spinal Muscular Atrophy (SMA) – August 4, 2022
Spinocerebellar Ataxia Type 3 (SCA3) External Link Disclaimer– September 22, 2023
Thymidine Kinase 2 Deficiency (TK2) External Link Disclaimer – January 31, 2022
Valosin Containing Protein Disease (VCP) External Link Disclaimer – May 5, 2020
Vascular Ehlers-Danlos Syndrome (VEDS) External Link Disclaimer – October 7, 2020
Von Hippel Lindau (VHL) External Link Disclaimer – June 11, 2020
X-Linked Myotubular Myopathy (XLMTM) (summary unavailable) – August 3, 2020
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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