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Will You Be Attending? FDA Reschedules Part 15 Public Hearing for September 12-13 (5 Month Delay)

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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…]

Regulation of the Stem Cell Market is a Tipping Point – Which Way Will It Fall?

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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…]

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