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Wednesday, September 28, 2016

StemGenex CSO Tells FDA at Hearing to Regulate Adult Stem Cell Therapies as 'Blood Tissue


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In a presentation at a U.S. Food and Drug Administration (FDA) public hearing earlier this month, the chief scientific officer of StemGenex Medical Group, Steven A. Brody, MD, PhD, said succinctly: “Stem cells have arrived and have captivated the scientific and medical communities. With this excitement comes responsibility and with this responsibility comes regulation.”
Steven Brody
Dr. Steven Brody (Courtesy of StemGenex)

The purpose of the FDA hearings, held at National Institutes of Health (NIH) facilities in Bethesda, Maryland, on Sept. 12–13, was to obtain comments on four Draft Guidances of Human Cells, Tissues and Cellular and Tissue-Based Products relating to the regulation of adult stem cell therapies from a broad range of stakeholders, including  healthcare professionals, clinicians, biomedical researchers, patients, tissue establishments, biological and device product manufacturers, and the public.
The FDA asked for feedback on the scope of its draft guidelines, ranging from the particular topics covered and questions posed, to the identification of additional issues not covered but for which guidance would be helpful, and whether the FDA’s recommendations for each topic were sufficiently clear and consistent to provide meaningful guidance.

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