The Food and Drug Administration has announced a public workshop entitled, “Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval.”
Purpose and Scope of FDA’s Public Workshop
According to the FDA, the purpose of the public workshop is to “identify and discuss scientific considerations and challenges to help inform the development of human cells, tissues, and cellular and tissue-based products (HCT/Ps) subject to premarket approval, including stem cell-based products.”
I registered recently and got a nearly instant registration confirmation by email:
Information on the FDA Public Workshop
Additional information on the event is shown below:
Date: September 8, 2016
Time: 8:30 am -5:00 pm EDT (registration begins at 7:45)
Location: Food and Drug Administration, White Oak Campus – 10903 New Hampshire Ave, Bldg 2 Great Room B&C, Silver Spring, MD 20903
Entrance: Entrance for the public workshop participants (non-FDA employees) is through Building 1, where routine security check procedures will be performed.
Webcast
For those located far away from Silver Spring, MD, there is a webcast as well, which will be broadcast via Adobe Connect.
To attend the event in person or to attend the live webcast, you will need to sign-up via Event Bright at this link.
You can also get complete information from the FDA at this site.
As many of those who read this blog are stakeholders from across the stem cell community, I hope to see many of you at the FDA’s White Oak Campus on September 8th.
It will be an important opportunity for people from across the United States to discuss restrictions on stem cell therapies and cellular-based product development within the U.S.
FDA’s Public Workshop vs. Public Hearing
The FDA is also holding a public hearing on “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products Part 15″ on September 12-13th, 2016. Click here to learn more about this upcoming FDA event.