Categoría: FDA
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Signature Cord Prime™ Receives Investigational New Drug (IND) Approval from FDA for Phase 1 Study in Patients with Symptomatic Osteoarthritis of the Knee
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The Wild West of Stem Cells in the U.S. With Roberta Shapiro, DO, FAAPMR
Roberta Shapiro, DO, FAAPMR, specializes in musculoskeletal pain disorders and regenerative medicine. She is also an assistant clinical professor of medicine at the prestigious Columbia University Irving Medical Center. Dr. Shapiro joined our founder, Neil Riordan, PA, Ph.D., in 2019 to discuss the state of stem cell therapy in the United States. Dr. Shapiro…
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FDA poised to outlaw breast reconstruction for breast cancer survivors using their own fat tissue
The U.S. Food and Drug Administration held public hearings for two days this week to allow for public commenting on proposed guidance relating to the regulation of human cells, tissues or tissue-based products. In its current form, this guidance will classify a woman’s own fat tissue as a drug when used in breast reconstruction procedures.…
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FDA DRAFT STEM CELL GUIDANCE DOCUMENTS EXPOSED AS IMPROPER RULEMAKING, BAD SCIENCE AND HEARTLESS PUBLIC POLICY
Go to Original Post on RickJaffe.com Today was a good day for people who want continued access stem cells outside of clinic trials, and also for people who want the FDA to allow faster access to this promising technology. There was a wide spectrum of opinions. Some stem cell companies involved in clinical trials wanted…