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…]