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Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products (Day 1)

Monday, September 12, 2016, 9:00:00 AM, 9 hours.

Description: The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including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 FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.
Author: Food and Drug Administration
Runtime: 9 hours
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Event ID: 19816