Dear Members,

We are writing to invite you to participate in an important phone call to help inform staff of the U.S. Food and Drug Administration (FDA) about the patient and caregiver experience of living with Hunter Syndrome. This is part of a “Listening Session” being co-hosted by FDA’s Patient Affairs Staff (PAS) and the National Organization for Rare Disorders (NORD).

The purpose will be to provide information from the patient and caregiver perspectives that will help FDA staff better understand the burden of living with this disease, and the needs and concerns of patients/caregivers.

FDA PAS and NORD are hosting a teleconference on February 4, from 1:30 – 3:00 p.m. Eastern Time, and will include a selected group of individuals affected by Hunter Syndrome. These individuals will have an opportunity to share first-hand with FDA staff their experiences of living with this rare disease.

There are a limited number of openings for participating in the session, therefore participants will be accepted on a first-come-first-serve basis assuming the participant meets the specific requirements.

If you are interested in participating on this call, please let us know by January 21 by filling out this brief survey:

Please see below my signature for more information on what to expect before during and after the session.

This is an important opportunity for the Hunter Syndrome community voice to be heard at FDA; we hope you will consider participating.


Canadian MPS Society

MORE INFORMATION ON LISTENING SESSION: Prior to this call, FDA staff will provide examples of the types of questions that may be asked. Please note, these are informal, non-regulatory, non-binding meetings. FDA will not discuss policy or guidance.

This teleconference will involve only FDA staff, NORD staff, and the identified members of the Hunter Syndrome community who choose to participate and meet the requirements. Participants will only be identified by their first name.

Following the listening session, FDA will post a high-level meeting summary on their website. While your name will not be included in the summary, the information you provide to the review staff might be included.