- In a statement, FDA Commissioner Scott Gottlieb, M.D., says the agency will be advancing a comprehensive policy framework in the coming months aimed at clarifying the "rules of the road" for developers of stem cell and regenerative medicine therapies so the regulatory process will be more efficient and less costly.
- He adds that the regulator will be increasing oversight and enforcement in order to rein in the "bad actors" that are endangering patients with unproven treatments.
- For example, it issued warning letter to a Florida site called US Stem Cell Clinic and its Chief Scientific Officer for marketing unapproved stem cell products and for "significant deviations" from good manufacturing practices. A recent on-site inspection found that the clinic was processing body fat into stem cells derived from the body fat and administering the product (intravenously and directly into the spinal cord) to patients with Parkinson's disease, amyotrophic lateral sclerosis, heart disease and other conditions. None of the products have been reviewed or approved by the FDA. The clinic has 15 days to respond with its plan to address the issues.
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