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.
It is my opinion – and one that is shared by most advocacy groups – that the large turn-out for the event was a successful effort to communicate patient concerns to the FDA and a way to indicate that more input is needed in the regulatory process.
The FDA has since announced that it will be rescheduling the event for an undetermined date.
While that is not particularly enlightening, the important update is that the agency now intends to schedule a scientific workshop to address the four draft guidances pertaining to the regulation of stem cells within the U.S.
Specifically, the FDA sponsored scientific workshop is intended 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.”
To learn more, see the full FDA update below, which can also be viewed at the FDA.gov website at this link.
Public Hearing; Request for Comments – Draft Guidances Relating to the Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products – Postponed
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give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has postponed the hearing, which will be rescheduled later this year at a date to be determined.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.
For future updates on the event, sign-up below.
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