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Regulation of Human Cells, Tissues or Cellular or Tissue-Based Products

Posted on April 21, 2016

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give stakeholders additional time to provide comments to the agency, FDA intends to extend the comment period for the draft guidance documents, and has rescheduled the hearing for September 12 and 13, 2016, at Masur Auditorium on the campus of the National Institutes of Health. The agency also intends to schedule a scientific workshop to identify and discuss scientific considerations and challenges to help inform the development of HCT/Ps subject to premarket approval, including stem cell based products.

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

FDA’s announcement will contain information on how stakeholders interested in speaking, can sign up to speak at the rescheduled hearing.

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