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

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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Previously Conducted Patient Listening Sessions

FDA-Requested Patient Listening Session Summaries

Patient-Led Listening Session Summaries

Learn more about Patient Listening Sessions: