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FDA Patient Listening Sessions are short meetings that last up to 90 minutes.
- During the FDA Patient Listening Session, it is important to focus on topics that are related to FDA’s regulatory work. This will ensure that your comments address issues that are most relevant to FDA’s work.
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 medical devices.
- Concerns related to your health insurance or provider, such as lack of coverage.
- Complaints or concerns about the quality of care from your doctor, medical/health provider, or a healthcare 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 my disease or condition.
To learn more about what the FDA does and does not do, please visit these pages:
What topics are suggested for patients and caregivers to talk about during FDA Patient Listening Sessions?
Symptoms
What would you recommend I share about my symptoms?
- What symptoms do you experience (currently or previously)?
- How do you treat or manage your symptoms?
- Which symptoms affect you the most?
- Which symptoms are hardest to manage or treat?
- Why are certain symptoms harder to manage or treat?
- How do your symptoms impact your daily life?
Diagnosis and Disease Progression
What would you recommend I share about my diagnosis and disease progression?
- When were you first diagnosed with the disease/condition?
- Has your disease/condition gotten better or worse over the years?
Treatments and Disease Management
What would you recommend I share about my current treatments and disease management?
- How are you currently managing your disease or symptoms?
- What kind of side effects or adverse events have you experienced when using a treatment?
- What medical products do you use to treat your disease/condition or manage your symptoms?
Considerations for Possible New Treatment
What would you recommend I share about a possible new treatment?
- Which symptom(s) would you most want the treatment to address?
- Would you still take it if didn’t completely cure your disease?
- What factors would increase or decrease willingness to take treatment?
- If the treatment had side effects, would you still want to take it?
- How much risk would you be willing to take with a new treatment?
- If slowed down how quickly your disease progresses, would you be willing to take it?
- If it did not address all your symptoms, would you still be interested in taking it?
Clinical Trial Preferences
What would you recommend I share about clinical research (clinical trials, natural history studies)?
- Have you ever participated in a clinical trial?
- Why have you or have you not participated in a clinical trial? What are the reasons?
- Would you want to participate in a clinical trial?
- What should researchers know when studying your disease?
- If you may be given a placebo instead of the product that is being tested, would you still participate? Why or why not?
- If you had to stop all your current treatments, would you still participate? Why or why not?
Quality of Life
What would you recommend I share about my quality of life?
- What does a typical day look like?
- How does your disease/condition affect your life?
- What specific activities are you unable to participate in or have difficulty with?
Anything else you recommend I share?
- What are your most important goals for a treatment?
- What risks are you willing to accept for a treatment?
Learn more about Patient Listening Sessions:
Patient Listening Sessions – Home
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Content current as of:
05/02/2025
