HLAA has received permission from the U.S. Food and Drug Administration (FDA) to host an Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) for People and Families Living with Sensorineural Hearing Loss on Tuesday, May 25, from 10 a.m.-3 p.m., U.S. ET. This is a YouTube Live virtual meeting, and all are welcome to attend. You can pop in and out of the live meeting. The meeting will be recorded, and the recording will be available 48 hours after the meeting. This is the FIRST meeting of this kind on hearing loss that the FDA has given permission to hold.
The purpose of HLAA’s Externally-Led Patient-Focused Drug Development Meeting is to hear directly from two representative panels of people with hearing loss, and people with hearing loss and their families attending remotely about the most burdensome symptoms they experience, what it is like to live with hearing loss, their assessment of treatments they are currently using, and what would they like to see in future treatments.
The voice of the person with hearing loss will be heard in order to develop therapies and devices for people with hearing loss. The meeting is open to all but key reviewers from the FDA will be present from three divisions:
- Center for Devices and Radiological Health-CDRH
- Center for Drug Evaluation & Research-CDER
- Center for Biologics Evaluation & Research-CBER (this includes OTAT-the Office of Tissues and Advanced Therapies)
Please register for the meeting so that you can receive important meeting updates, including the link to login on the day of the meeting.
HLAA held an April 8 webinar that provided an overview of our May 25 EL-PFDD meeting. The webinar PowerPoint slides and recording are online.
Follow the meeting conversation on social media, #HLAA_PFDD.
The HLAA Externally-Led Patient-Focused Drug Development Meeting (EL-PFDD) comments page will be going live on Monday, May 10. All meeting comments will be coming into the pfdd@hearingloss.org mailbox here at HLAA.
Questions? Please email Amanda Watson at webinars@hearingloss.org.