Planning an FDA Patient-Led Listening Session

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Planning for an FDA patient-led listening session typically takes four to six months. After the Patient Listening Session has been scheduled, the patient(s)/organization who requested the listening session should:

1. Work with other patient organizations/groups within the same disease area/health condition to collaborate on the listening session.
2. Have approximately three total meetings with FDA:
   • Meeting 1 (an introductory meeting): discuss logistics of planning a listening session with the FDA.
   • Meeting 2 (planning meeting): review the agenda and meeting materials with the FDA.
   • Meeting 3 (preparation meeting): practice/dry run of the listening session in preparation for the listening session.
3. Send final agenda and meeting materials to FDA Public Engagement Staff at least two weeks prior to the listening session.
4. Share, in advance, any financial interests that patients, caregivers, clinicians, or organizations participating may have related to this Patient Listening Session topic.
5. Conduct the FDA patient-led listening session over Teams.

Learn more about Patient Listening Sessions:

Patient Listening Sessions – Home

• Content current as of:

  05/02/2025

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