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…]