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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
          How do I request a Patient Listening Session?Learn About FDA Patient Engagement How do I request a Patient Listening Session?
  
  	
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    PrintThank you for your interest in requesting a Patient Listening Session!

Please read all of the information in the sections below before submitting your request. If you are unsure if a Patient Listening Session is the best way to talk to FDA, the Office of Patient Affairs can help! Contact us through the Patients Ask FDAwebform, by email at PatientAffairs@fda.gov or by phone at 301-796-8460.

What are Patient Listening Sessions and how can you participate?
	Patient Listening Sessions are one of many ways patients, caregivers, and their advocates can share their experiences and perspectives by talking directly with FDA staff.

Patient Listening Sessions are small, informal, non-regulatory, non-public discussions
	Patient Listening Sessions are scheduled for up to 1.5 hours and can be in person at FDA in Silver Spring, MD, on the phone, or a mix of the two
	Patient Listening Sessions are about your health-related experiences and perspectives, not a specific medical product (drug, biologic, or device)Only the FDA, patients, caregivers, advocates, and community representatives participate in the Patient Listening Session. For some sessions, FDA's Office of Patient Affairs works in partnership with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation for the FDA. FDA staff will listen to better understand your experiences and perspectives and may ask questions to learn more.

How does FDA benefit from Patient Listening Sessions?
	Patient Listening Sessions help FDA understand what is important to you and your patient and advocacy community when medical products are being developed.

What are the criteria for a Patient Listening Session?
	The Office of Patient Affairs will work with you to see if a Patient Listening Session is the best way to talk with FDA. Patient Listening Sessions:

Are small, informal, non-regulatory, non-public teleconference meetings
	Allow participants to share their experiences and perspectives with FDA staff first-hand
	About patient experiences, perspectives, and needs related to their health or a disease, and not about specific medical products (drug, biologic, or device)
	An opportunity for the FDA 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
	Of interest to medical product center 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


What information does the FDA need for your request?
	SUBJECT/TOPIC OF PATIENT LISTENING SESSION
List the subject(s) that you plan to discuss with the FDA. Describe the patient population along with health condition, disease or your specific concern.

DESIRED MEETING GOALS
Describe why you want to meet with FDA. Describe what you hope FDA will learn. Describe what you hope to gain from a Patient Listening Session.

PATIENT LISTENING SESSION TOPICS
Describe the topics you would like to cover in this Patient Listening Session about the patient’s experience.

PROPOSED DRAFT MEETING AGENDA
Example: Draft Agenda

FDA Opening Remarks (3 min) - Patient Affairs
	Disease Overview (5-10 min)
	Patient/Caregiver Testimonials (30-60 min) - 5 to 7 speakers
	FDA Open Discussion (10-15 min) - Patient Affairs
	FDA Closing Remarks (2 min) - Patient Affairs.


How do I request a Patient Listening Session?
	Follow these steps to start your request for a Patient Listening Session:

1.  Go to www.fda.gov/PatientsAskFDA

2.  Complete the form

3.  Under the section about the FDA Programs, click: “Patient Listening Sessions” In remaining boxes on the form, enter the information from the section above including:

the health condition, disease or your specific concern;
	what you would like to share during the patient listening session;
	a draft meeting agenda; and
	what you hope to happen after the patient listening session4.  Click “Submit”

We will review the request for completeness, evaluate the request, and follow up with you. In the meantime, check out summariesfrom previous 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?

Patient Listening Sessions - Home

                                                                                  Content current as of:
      02/22/2023
              
              
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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