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  1. FDA Patient Listening Sessions

About FDA-Requested Patient Listening Sessions

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Was I selected to participate in an FDA-Requested Patient Listening Session?

  1. Did you complete an online survey about your experience living with or managing a disease or condition?
  2. Did someone from the FDA Public Engagement Staff, or one of our partners such as the National Organization for Rare Disorders (NORD) External Link Disclaimer and the Reagan-Udall Foundation for the FDA External Link Disclaimer. (also known as The Foundation) contact you about participating in an FDA Patient Listening Session?

If you answered “yes” to both questions above, you were selected to participate in an FDA-Requested Listening Session.

  • Staff from the FDA Public Engagement Staff, NORD, or The Foundation will reach out to you by email or phone to confirm if you are still interested in participating in the FDA-Requested Patient Listening Session.

If you choose to participate in an FDA-Requested Patient Listening Session:

  • Prior to the date of the meeting, we will meet with you over the phone to provide information about the FDA-Requested Patient Listening Session and answer any questions that you may have about the Patient Listening Session.
  • Prior to the date of the meeting, we will email you a list of discussion questions that you will be asked during the session.
  • Please review the questions in advance and write down your responses or key points before the session. The list of questions is usually five to seven open ended questions.
  • You will be provided with instructions on how to join the session. To log-on to the session, you will need to have access to a phone.

During an FDA-Requested Patient Listening Session:

  1. A representative from FDA Public Engagement Staff will provide welcome remarks and share reminders about the meeting.
  2. FDA staff will then ask the first question and then ask each participant to answer the question. After each person answers the first question, FDA will proceed with asking the remaining questions.
  3. You may be asked questions related to your feelings and opinions about any of the following topics: symptoms; treatments; clinical trial preferences; desired endpoints in clinical trials; and benefit/risk perspectives.

Learn about Patient Listening Sessions:

Patient Listening Sessions - Home

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