FDA regenerative medicine advanced therapy

US Stem Cell bid for FDA RMAT rejected?

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Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The …

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FDA warp speed RMAT approval nukes stem cell clinic excuses

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Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality. Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true. …

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