HLAA’s Externally-Led Patient-Focused Drug Development (PFDD) Meeting FAQs
Tuesday, May 25, 2021, 10 a.m.-3 p.m. (U.S. ET)
What is this meeting? What does it mean?
The Hearing Loss Association of America (HLAA) received permission from the U.S. Food & Drug Administration (FDA) to hold an Externally-Led Patient-Focused Drug Development Meeting for People and Families Living with Sensorineural Hearing Loss on Tuesday, May 25, from 10 a.m.-3 p.m. (U.S. ET).
This meeting represents the voice of the person with hearing loss. Two panels will speak about their experiences living with hearing loss. Meeting attendees will have the opportunity to call in and submit online written comments about the issues discussed during the meeting. All meeting comments collected before, during and in the 30 days following the meeting will be included in a “Voice of the Patient” report to be published a few months after the meeting.
People can participate live the day of the meeting or send in questions and comments ahead of time here. You may join part of the live meeting if your schedule allows for that; you can come in and out of the live meeting. If you cannot join the live meeting, we encourage you to view the meeting recording, which will be available on May 27, 2021.
1. Should I register for the meeting in the meeting in advance? What is the meeting registration link?
Yes, register here by Friday, May 21: https://pfdd-hlaa-meeting-registration.gr8.com/. You will receive meeting updates, including emails from HLAA about how to access the live meeting. Didn’t register in time? No worries! Our meeting access form opens on May 24 or 25. You can fill in this form to access the live meeting video player.
2. HELP! I cannot get into the live meeting. Whom do I contact?
Email email@example.com. Our HLAA staff (Ann and Carla) will be monitoring this email address on Tuesday, May 25, between 9 a.m.-3 p.m. Ann and/or Carla will respond to your query as soon as possible.
3. Will this meeting be hearing accessible?
Yes, this meeting includes real time captioning and American Sign Language interpretation.
4. What is this “Interactive Virtual Meeting?
5. I cannot attend the live meeting. Will this meeting be recorded, and when will the recording be available?
This meeting will be recorded. The meeting recording will be available 48 hours after the May 25 meeting (i.e., on May 27, 2021). Come back to this page: https://www.hearingloss.org/hlaa-pfdd/ to view the meeting recording and read the captioned meeting transcript. The meeting recording link will “go public” on YouTube on June 25, 2021.
6. I want to see the meeting agenda. Will that be released, if so, when?
The meeting agenda (pdf) will be posted online here the week of May 10.
7. I want to submit meeting comments. How do I do that? When can I do that?
The meeting comment box went live on Monday, May 10 here: https://www.hearingloss.org/hlaa-pfdd/. Individuals can submit comments before the meeting, on the day of the meeting, or in the 30 days after the meeting (through June 25, 2021) through the comment box on the aforementioned web page. You may also email comments to firstname.lastname@example.org.
Most meeting comments collected before, during and in the 30 days following the meeting will be included in a “Voice of the Patient” report to be published this fall. The comments that are not included in the report will be shared in a separate, online PDF. By submitting a comment, you are agreeing that HLAA has your permission to publicize your first name and last initial with your comment in the “Voice of the Patient” report, and in the online document with comments that are not included in the “Voice of the Patient” report.