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“The purpose of the public hearing is to obtain comments on the four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps) from a broad group of stakeholders, including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  FDA will consider information it obtains from the public hearing in the finalization of the four draft guidance documents.”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.

3 thoughts on “FDA stem cell meeting now a 2-day public event in September”

  1. I would like to explore, does the FDA have a position on Nano-Formulated growth factors as a therapeutic?

    This is because the NanoMed approach is strongly complimentary to current RegMed approaches to therapy and the potential synergy of outcome between RegMed and NanoMed warrants early strategic consideration at regulatory level, and I am not sure if this is already in place?

    NanoMed – although young – represents a new era in medicine. By targeting natural regulatory pathways – for example within the CNS – sustained paracrine-type delivery of growth factor enabled by nanotechnology has the potential to harness homeostatic controls that may become self-sustaining.

    Accordingly, within the RegMed space, NanoMed provides a scalable solution to the need for an off-the-shelf medicinal of universal applicability.



Comments are closed.