Facilitate Scientific Collaborations
Other FDA Meeting Opportunities
The FDA offers additional opportunities to meet with patient groups early in therapy development. If you are uncertain which meeting type and the timing of your request to meet, contact the FDA Patient Affairs Staff at (301) 796-8460 or PatientAffairs@fda.hhs.gov. Other FDA meeting opportunities include:
- Patients Ask FDA: FDA Patient Affairs Office and the FDA medical product centers developed the Patients Ask FDA portal to allow patients and the groups like yours that advocate for them to submit questions and requests for meetings.
- Requested meetings may focus on sharing patient disease experience or better understand the FDA’s marketing review process.
- The staff of the FDA Patient Affairs Office will route the questions or meeting requests to the appropriate medical product center or office.
- Patient Listening Sessions: Patient Listening Sessions are hosted by the FDA Patient Affairs Office and the National Organization for Rare Disorders (NORD) , a nonprofit group uniting rare disease patient groups.
- FDA, patients, caregivers, and advocates participate in the session.
- Small, informal, non-regulatory, non-public discussions.
- About disease experiences, not a specific therapy.
- FDA staff will either ask questions or simply listen to better understand your experience with a disease or condition.