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  3. Learn About FDA Patient Engagement
  4. FDA Patient Listening Sessions
  1. Learn About FDA Patient Engagement

FDA Patient Listening Sessions

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What are FDA Patient Listening Sessions

Upcoming scheduled Patient Listening Session topics:

  • MECP2 Duplication Syndrome

The FDA Public Engagement Staff hosts Patient Listening Sessions to connect patients, caregivers, and patient organizations directly with the FDA. Patients can discuss their health condition and help us understand what is most important, including the physical and emotional burdens.

FDA Patient Listening Sessions can be patient-led (when a patient community wants to share their perspectives with the FDA) or FDA-requested (where the FDA has a specific set of questions to ask patients or caregivers).

FDA Patient Listening Sessions are:

  • Private, small, informal, non-regulatory, non-binding virtual meetings that allow participants to connect with FDA staff.
  • With the FDA, patients, caregivers, patient advocates and patient community representatives (medical product industry does not attend).
  • About patient experiences, perspectives and needs related to their health or a disease.
  • Related to two or more of FDA’s medical product programs (drugs, biologics or devices).
  • Not about a specific investigational (not FDA-approved) drug, device, or biologic.
  • Not about the same set of agenda topics as previous or upcoming meetings with the FDA.
  • Part of a collaboration with the National Organization for Rare Disorders (NORD) and the Reagan-Udall Foundation for the FDA.

FDA Patient Listening Sessions can:

  • Give the FDA an opportunity to connect with patient communities.
  • Help the FDA better understand what is most important to different communities and individuals who have specific health, medical and treatment needs.
  • Educate FDA’s review staff about health-related experiences, perspectives and needs that are most important to patients, caregivers, advocates, and community representatives.
  • Provide insights that may inform regulatory decision making.

FDA Patient Listening Session Summaries:

The FDA publishes high-level FDA-requested patient listening session summaries and Patient-led listening session summaries (if provided by the requestor) online after each session.

The following topics are outside the scope of the Agency’s mission and/or the Patient Listening Session program:

  • Specific clinical trials and investigational or unapproved medical products (in other words, products that are still being studied and tested in research or clinical trials to ensure they are safe and effective).
  • The cost or price of treatments, such as drugs, medications, or devices.
  • Concerns related to your health insurance or provider, such as lack of coverage.
  • Complaints or concerns about the quality of care you have received from a doctor, medical/health provider, or a health care facility like a hospital.
  • Suggestions about health care provider curriculum, education, or training.
  • Concerns about your health care provider’s experience or license.
  • Lack of specialists who treat or know about your disease or condition.

Contact Us

Email: ForPatients@fda.hhs.gov
Patients Ask FDA Webform
Phone: 301-796-8460

 

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