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  1. Learn About FDA Patient Engagement

Patient Listening Sessions

FDA’s Office of Patient Affairs in partnership with the National Organization for Rare Disorders (NORD) and Reagan-Udall Foundation for the FDA is excited to host Patient Listening Sessions! Patient Listening Sessions are a resource for the medical product Centers to quickly engage with patients or their advocates and are one of many ways the patient community can share their experience with a disease or condition by talking directly with FDA staff.

Patient-Led Listening Sessions are currently being scheduled for Fall 2021.

Upcoming Patient Listening Session topics include Lupus, SCN2A Related Disorders, and Adrenomyeloneuropathy (AMN).

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:

Many people in the shape of an ear
  • Small, informal, non-regulatory, non-public discussions
  • About disease experiences, not a specific medical product (drug, biologic, or device)
  • Of interest to medical product 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

During a Patient Listening Session, FDA staff will either ask questions or simply listen to better understand your experience with a disease or condition. Only the FDA, patients, caregivers, and advocates participate in the session.

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:

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. FDA does not cover the travel expenses of participants coming to campus.

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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