September 30, 2020

The Niche

Knoepfler lab stem cell blog

Breaking: FDA postpones big stem cell public meeting

FDA draft guidanceThe FDA has delayed the planned big April public meeting on stem cells until later this year.

Basically, the reason given is that more time is needed for stakeholders to comment.

It will be interesting to see if the FDA expands the meeting beyond the 1-day format, which was going to allow each speaker only 3 minutes. It would be helpful I think if the FDA held the meeting in a more centrally located city as well. I’m hoping now I might be able to attend.

The delay in this meeting risks leaving the stem cell regulatory sphere related to four recent draft guidances up in the air for a longer period of time, but we’ve seen from the recent stem cell clinic warning letter that the FDA will still take action based on its current thinking. You can also read my interview last week with the FDA on this meeting and the draft guidances here.

The announcement on the FDA website reads:

“There has been considerable interest in the Public Hearing, “Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products,” scheduled to take place on April 13, 2016.  Due to this interest, and to give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined.  The agency also intends to schedule a scientific workshop to gather information from manufacturers of cell based products, clinical researchers, and other stakeholders regarding the generation of scientific evidence to facilitate the development of safe and effective cell based therapeutics.

Information on the rescheduled hearing, including date, location and registration information, will be made available on FDA’s website and will be published in the Federal Register.  We will announce the dates for the hearing and the workshop in the near future.

FDA’s announcement will contain information on how stakeholders interested in speaking, including those who were scheduled to speak at the hearing on April 13th, can sign up to speak at the rescheduled hearing.”


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