Skip Navigation


CIT can broadcast your seminar, conference or meeting live to a world-wide audience over the Internet as a real-time streaming video. The event can be recorded and made available for viewers to watch at their convenience as an on-demand video or a downloadable podcast. CIT can also broadcast NIH-only or HHS-only content.

Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (Day 2)

Loading video...

945 Views  
   
Air date: Tuesday, September 13, 2016, 9:00:00 AM
Time displayed is Eastern Time, Washington DC Local
Views: Total views: 945, (542 Live, 403 On-demand)
Category: Conferences
Runtime: 04:16:34
Description: The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public. For example, FDA would like comments on the scope of the four draft guidances, including the particular topics covered, the particular questions posed, whether there are additional issues for which guidance would be helpful, and whether FDA’s recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders. In addition, FDA welcomes comments that will enhance the usefulness and clarity of these documents. FDA recommends that comments exclude discussion of products that do not meet the definition of an HCT/P, such as platelet rich plasma and other blood products. FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.
Debug: Show Debug
Author: Food and Drug Administration
Download: To download this event, select one of the available bitrates:
[64k]  [150k]  [240k]  [440k]  [740k]  [1040k]  [1240k]  [1440k]  [1840k]    How to download a Videocast
Caption Text: Download Caption File
CIT Live ID: 19820
Permanent link: https://videocast.nih.gov/launch.asp?19846