FDA draft guidances stem cells

Internal FDA Fighting on Sarepta Bad Omen for Stem Cell Oversight?

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The FDA caused major controversy by approving the drug Exondys 51 from Sarepta Therapeutics for treating Duchenne muscular dystrophy over the recommendations of a scientific panel it convened that had voted 7-3 against approval. Is this contentious Sarepta approval serve as a sign of how the FDA will deal with stem cells moving forward? Will the FDA approval, which …

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4,000+ comments on FDA stem cell guidances, mostly clones of “My cells are my cells”

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Keep your hands off of my cells! At least, that is what many are telling the FDA regarding stem cells. The FDA issued four draft guidances related to stem cells in the past year or so, held two public stem cell meetings, and now must decide what it is going to do with an out …

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