Patient Listening Session Summaries

Discussions in Patient Listening Sessions are informal. All opinions, recommendations, and proposals are unofficial and nonbinding on the 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., The 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: