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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
          FDA Patient Listening SessionsLearn About FDA Patient Engagement FDA Patient Listening Sessions
  
  	
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    PrintFDA Patient Affairs hosts Patient Listening Sessions. These sessions are a resource for the medical product Centers to engage with patients and their advocates. Patient Listening Sessions are one of many ways the patient and advocacy community can share their experiences and perspectives by talking directly with FDA staff.******

Upcoming scheduled Patient Listening Session topics:

Attention-Deficit/Hyperactivity Disorder (ADHD)
	Congenital Cytomegalovirus Infection (cCMV)
	KCNT1-Related Epilepsy
	Neurofibromatosis Type 1 (NF1)/Cutaneous Neurofibroma(cNF)
******

What are Patient Listening Sessions?

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). Patient Listening Sessions:



Are small, informal, non-regulatory, non-public teleconference meetings that allow participants to connect with FDA staff first-hand
	Are about patient experiences, perspectives, and needs related to their health or a disease, and not about specific medical products (drug, biologic, or device)
	Should include multiple patient groups/communities within a disease area
	Give the FDA an opportunity to connect with under-represented communities
	Help the FDA better understand what is most important to different communities and individuals who have specific health, medical, and treatment needs
	Should be of interest to medical product center staff in multiple FDA Centers/programs
	Should not be on the same set of agenda topics as a past meeting held or future meeting planned with FDAPatient Listening Sessions help the Agency inform medical product development, clinical trial design, patient preferences, and shape our regulatory thinking. During a Patient Listening Session, FDA staff will either ask questions or simply listen to better understand your experiences and perspectives. Only the FDA, patients, caregivers, advocates, and community representatives participate in the session. FDA Patient Affairs partners with the National Organization for Rare Disorders and the Reagan-Udall Foundation for the FDA.

Click here for Summaries of Patient Listening Sessions
******

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?

******

**Read about the impact Patient Listening Sessions can have on FDA's work:**

Determining Commonalities in the Experiences of Patients with Rare Diseases: A Qualitative Analysis of US Food and Drug Administration Patient Engagement Sessions
	FDA engages patient communities through listening session initiative
	How FDA is Putting the Patient Voice at the Forefront of Gene Therapy Clinical Trials for Hemophilia
	Transgender teens share perspectives on health care needs during listening sessionRead about the procedures for the management of Patient Listening Sessions by the 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.

                                                                                  Content current as of:
      01/23/2024
              
              
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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