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 In this section:

                Learn About FDA Patient Engagement

Learn About FDA Patient Engagement

                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities Home
          For Patients
          Learn About FDA Patient Engagement
          Patient Listening Session SummariesLearn About FDA Patient Engagement Patient Listening Session Summaries
  
  	
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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
	Carcinoid Syndrome – April 27, 2023
	Celiac Disease- February 20, 2019
	Childhood Cerebral Adrenal Leukodystrophy (CCALD) - November 13, 2019
	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, 2020Patient-Led Listening Session Summaries

Adrenomyeloneuropathy (AMN) External Link Disclaimer - May 7, 2021
	Adult Dermatomyositis External Link Disclaimer – April 26, 2022
	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
	Biliary Atresia, Progressive Familial Intrahepatic Cholestasis, Wilson's Disease (summary unavailable) - November 5, 2018
	Canavan Disease External Link Disclaimer- March 21, 2023
	C. difficile Infections External Link Disclaimer- March 10, 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
	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
	Late Onset GM2 gangliosidoses (Tay-Sachs and Sandhoff diseases) - January 15, 2021
	Leukoencephalopathy with brainstem and spinal cord involvement and lactate elevation (LBSL) (summary coming soon) - May 30, 2023
	Limb Girdle Muscular Dystrophies (LGMD) External Link Disclaimer - October 20, 2020
	Mastocytosis External Link Disclaimer – September 28, 2021
	Narcolepsy and Idiopathic Hypersomnia External Link Disclaimer – August 8, 2022
	Neurofibromatosis (NF) External Link Disclaimer - June 13, 2019
	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
	Osteoarthritis (OA) External Link Disclaimer - August 7, 2019
	Osteogenesis Imperfecta (OI) External Link Disclaimer - September 17, 2019
	Pelizaeus Merzbacher Disease (PMD) (summary coming soon) - August 22, 2023
	Pemphigus and Pemphigoid External Link Disclaimer - February 8, 2021
	Post-finasteride Syndrome (PFS) - June 2, 2023
	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, 2020Learn 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.

**Disclaimer:**Our website has links to other organizations. You should be aware that:

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                                                                                  Content current as of:
      01/10/2024
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesLearn About FDA Patient Engagement

          
                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities
 
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