Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) Meeting - Day 1
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Күн бұрынThe CTGTAC committee will meet in open session on both days to discuss the toxicity risks of adeno-associated virus (AAV) vector-based gene therapy products. The discussion topics include safety issues identified during preclinical and/or clinical evaluation, and oncogenicity risks due to vector genome integration.
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U.S. Food and Drug Administration
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Serious liver injury being observed in patients without cirrhosis taking Ocaliva (obeticholic aci...
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U.S. Food and Drug Administration
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