The Patient Listening Session is scheduled! Now what? The Office of Patient Affairs (OPA) will be in contact with you in the weeks leading up to the session. If you have any questions, don’t hesitate to call or email OPA! In the meantime, this page will help you prepare for the upcoming Patient Listening Session.
Develop your meeting materials and refine your agenda – The Office of Patient Affairs (OPA) can help you develop an agenda for a successful Patient Listening Session
- Identify the main messages you want to share with FDA
Send your final agenda and any additional materials such as background documents and slide presentations to OPA at least 2 weeks before the Patient Listening Session
Example: Draft Agenda
- FDA Opening Remarks (3 min) - Patient Affairs
- Disease Overview (5-10 min)
- Patient/Caregiver Testimonials (30-60 min) - 5 to 7 speakers
- FDA Open Discussion (10-15 min) - Patient Affairs
- FDA Closing Remarks (2 min) - Patient Affairs
Identify participants – Identify and confirm the attendance of participants from the patient community
- For in-person Patient Listening Sessions, send OPA a list of attendees a week prior to the meeting
- Identify if any participants are not US citizens and notify OPA at least 3 weeks before the meeting
- Identify if any participants require special accommodations and notify OPA as soon as possible, but at least a week before the meeting
Plan your transportation to and from FDA – For in-person Patient Listening Sessions, consider whether you will be dropped off at FDA, park in the visitor lot, or take public transportation.
FDA believes that the Agency and the public benefit from a transparent process to ensure that information is used to make well-informed decisions. If you have any financial interests related to this Patient Listening Session topic, you are encouraged to share these interests in advance. Such interests may include:
- A company or group pays for your travel or other expenses.
- A medical product company gives you money for a grant.
If you do not have anything to share, you may wish to state that for our purposes. If you prefer not to share your financial interests at this time, you may still participate in the Patient Listening Session.
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OPA will provide you with the building number prior to the Patient Listening Session. OPA selects conference rooms that allow for a collaborative discussion between the patient community and FDA staff. If participating by teleconference, OPA will provide you will a phone number and meeting ID in advance.
Participants parking at FDA should arrive at the visitor parking lot an hour and 15 minutes before the start of the session. While driving to the lot, you will go through a vehicle security checkpoint.
Participants being dropped off at FDA should arrive an hour before the start of the session. You will be dropped off at Building 1.
Call, text, or email OPA to notify us of your arrival. Enter Building 1 and sign into the Visitor Management System. Be prepared to show a government-issued photo ID. You must undergo security procedures similar to those at the airport. Be prepared to remove your laptop and power cables from your bags.
OPA will meet you at security and escort to the meeting room. OPA will escort you during your entire visit at FDA.
OPA will open up the meeting and read a brief disclaimer. Then, you will lead the Patient Listening Session according to your agenda. We recommend allowing 15 minutes at the end of the meeting for an open discussion. FDA may use this time to ask clarifying questions.
Things to remember during the Patient Listening Session:
- FDA staff will listen and learn from you but may not be able to address your questions or concerns during the session
- If participating by phone, identify a quiet place to take the call and plan to join 15 minutes before the scheduled start time; when not speaking, put yourself on mute to eliminate background noise
- Patient Listening Sessions are not recorded/transcribed and are not public meetings