Your Global Leader in Stem Cell Market Research
On September 12-13th, 2016, the FDA hosted a public hearing to review draft guidances pertaining to the FDA regulation of stem cells.
More specifically, the hearing addressed the regulation of human cell and tissue-based products (HCT/Ps), defined by the FDA in § 1271.3(d) as “articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.” [Read more…]
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.” [Read more…]
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. [Read more…]
The stem cell market has grown increasingly complex over the past few years, especially in the regulatory space. The NIH recently had an overwhelming response for participation in its Part 15 public hearing intended to review “Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products.”
With approximately 600 registrations for the events and 100 people and groups interested in presenting, it was clear that individuals across the United States are concerned about these draft guidances that appear to be a further restriction on stem cell therapy within the U.S. The event has since been rescheduled as a two-day public hearing to be held over September 12-13, 2016, in a larger venue, Masur Auditorium, at the NIH campus in Bethesda, MD. [Read more…]
Recently, we released a post titled “The Good, The Bad, and The Ugly of the Postponed FDA Public Hearing (Part 15) – Draft Guidances Controlling Stem Cells.” In that article, we explored the overwhelming response received by the FDA for participation in an event intended to review four draft guidances controlling the regulation of human cells and tissues within the U.S.
With approximately 600 registrations for the events and 100 people and groups interested in presenting, it was clear that people across the United States are substantially concerned about the draft guidances that appear to be a further restriction on stem cell therapy within the U.S. [Read more…]
