January 21, 2021

The Niche

Trusted stem cell blog & resources

FDA stem cell meeting now a 2-day public event in September

FDA stem cell meetingThe FDA stem cell meeting that was supposed to take place in April is now officially going to be a 2-day event in September.

This public meeting is meant to get comments on four draft guidances related to regs on stem cell products and treatments.

From the FDA announcement on the meeting:

“The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including tissue establishments, biological and device product manufacturers, health care professionals, clinicians, biomedical researchers, and the public.  For example, FDA would like comments on the scope of the four draft guidances, including the particular topics covered, the particular questions posed, whether there are additional issues for which guidance would be helpful, and whether FDA’s recommendations for each topic are sufficiently clear and consistent within and across documents to provide meaningful guidance to stakeholders.  In addition, FDA welcomes comments that will enhance the usefulness and clarity of these documents.  FDA recommends that comments exclude discussion of products that do not meet the definition of an HCT/P, such as platelet rich plasma and other blood products.  FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.”

If you want to attend or speak at this September meeting you must register your interest here. It looks like the slots for speaking are already “sold out” according to the website, which would be unfortunate if correct.

Hat tip to Jeanne Loring on the re-scheduled meeting.

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