Recently, we explored the overwhelming response received by the FDA for participation in its Part 15 Hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations and 100 people interested in presenting, it was clear that individuals across country are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S.
As a result of this massive registration response, the FDA cancelled the original April 13, 2016, hearing date and announced that it would be rescheduled for an undetermined date.
Since that time, the FDA announced that it intended to schedule a “scientific workshop” to address the four draft guidances pertaining to the regulation of stem cells, stating:
The agency also intends to schedule a scientific workshop to identify and discuss scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell based products.
This workshop has since been scheduled for September 8th, 2016. Click here for details about the workshop and how to register.
Rescheduled Date Announced for the FDA Part 15 Hearing
On April 13, 2016, the FDA finally announced the rescheduled date for the FDA Part 15 Hearing, which will occur five months later than the one originally scheduled event.
The hearing was rescheduled for September 12-13, 2016, at Masur Auditorium on the campus of the National Institutes of Health, in Bethesda, Maryland.
Two-day format is a substantial improvement over the original one-day format that would had allotted each speaker and presenting group only 3 minutes of time. The larger venue size is also an improvement, as the FDA designated an auditorium this time around.
See the image below to identify access points to the event within the Warren Grant Magnuson Clinical Center, which is contiguous with the Mark O. Hatfield Clinical Research Center:
Registration Process for the Rescheduled FDA Part 15 Hearing
Unfortunately, registration for the rescheduled FDA Part 15 Hearing did not begin immediately after the date was announced.
To register for the original April 13th public hearing, an email had to be sent to “CBERPublicEvents@fda.hhs.gov”. For this reason, I tried emailing that address on April 15th to register for the rescheduled event.
Unfortunately, I received a reply from FDA Public Affairs Specialist, Loni W. Henderson, stating:
Registration for the rescheduled hearing has not yet begun. Information on how to register for the subject event will be made available at the below link shortly. You will need to check this link for information on how to register through our Eventbrite system.
http://www.fda.gov/BiologicsBloodVaccines/NewsEvents/
WorkshopsMeetingsConferences/ucm462125.htm
Thankfully, the EventBrite system went live a couple weeks later and I was able to successfully register, as shown by my ticket below.
Turnout for the rescheduled FDA Part 15 Hearing?
One unknown that the FDA cannot control but which substantially interests me is what the total attendee count will be for the rescheduled hearing. How much will it exceed the 600 registrations received for the cancelled April 13th hearing?
By my estimations, the rescheduled event is likely to get 200-300% more registrations than the original, putting total attendee count at approximately 1,200 to 1,800.
After all, event attendees will have five more months to make travel plans and arrangements.
To learn more about the event, view the FDA page at this link. Unfortunately, people (including FDA employees) who wanted to attend or speak at the public hearing had to register by June 1, 2016.
However, the FDA will make a link to an Event Webcast available at that page, so mark your calendars for September 12-13, 2016, and plan to tune in.
It is important that stakeholders from across the stem cell community participate in this crucial event.