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 In this section:

                Learn About FDA Patient Engagement

Learn About FDA Patient Engagement

                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities Home
          For Patients
          Learn About FDA Patient Engagement
          How do I prepare for a Patient Listening Session?Learn About FDA Patient Engagement How do I prepare for a Patient Listening Session?
  
  	
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    PrintThe 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.

Next Steps for Patient-Led Listening Sessions
	Woman on phone working at computer
**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.

See: Driving Directions and Parking, FDA White Oak Campus

Financial Interests and Patient Listening Sessions
	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.

Listening Session Location
	FDA’s Address:
10903 New Hampshire Avenue
Silver Spring, MD 20993

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.

Arriving at FDA
	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.

Greeting in Lobby Handshake
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.

During the Patient Listening Session
	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.

Writing on a notepad while sitting
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

Learn more about Patient Listening Sessions:

How does FDA benefit from Patient Listening Sessions?

How do I request a Patient Listening Session?

How do I prepare for a Patient Listening Session?

What happens after a Patient Listening Session?

Patient Listening Sessions - Home

                                                                                  Content current as of:
      05/11/2022
              
              
Regulated Product(s)
		 Biologics
			  			     			  			     Drugs
			     			  			     Medical DevicesLearn About FDA Patient Engagement

          
                        About the FDA Patient Representative Program
          When a Patient Speaks: Testimonials from FDA Patient Representatives
          How to Apply to the FDA Patient Representative Program
          FDA Patient Engagement Overview*
          FDA Patient Listening Sessions
          Patients Ask FDA
          Patients Matter Video Series
          Patient Engagement Collaborative
          Patient Engagement Cluster
          About the FDA and How You Can Get Involved


                        FDA Patient Engagement Opportunities
 
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