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.

Resources

Organize In-Person Scientific Meetings
List of Registries National Institutes of Health Clinical Center (link)
NIH Support for Scientific Conferences (R13 and U13) National Institutes of Health (NIH) (link)
FAQs about R13 grants National Institutes of Health (NIH) (link)
NIH Programs Supporting Collaboration
Office of Advocacy Relations National Cancer Institute (NCI) (link)
Patient/Community Engagement & Health Information National Center for Advancing Translational Sciences (NCATS) (link)
Work with NCATS National Center for Advancing Translational Sciences (NCATS) (link)
Rare Disease Clinical Research Network (RDCRN) National Center for Advancing Translational Sciences (NCATS) (link)
RDCRN Funding Information National Center for Advancing Translational Sciences (NCATS) (link)
RDCRN Conference on Clinical Research for Rare Diseases (CCRRD) National Center for Advancing Translational Sciences (NCATS) (link)
FDA Critical Path Innovation Meeting
Cooperative Research and Development Agreement (CRADAs) U. S. Food and Drug Administration (FDA) (link)
FDA Critical Path Innovation Meetings U. S. Food and Drug Administration (FDA) (link)
Video on the Critical Path Innovation Meeting (CPIM) Program U. S. Food and Drug Administration (FDA) (link)
Other FDA Meeting Opportunities
Patients Ask FDA U. S. Food and Drug Administration (FDA) (link)
Patient Listening Sessions U. S. Food and Drug Administration (FDA) (link)