CTGTACCellular Tissue and Gene Therapies Advisory Committee
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References in periodicals archive ?
The Office of Cellular, Tissue and Gene Therapies' (OCTGT) own committee, the Cellular, Tissue and Gene Therapies Advisory Committee (CTGTAC), is tasked to discuss cell-therapy products.
USA regulatory framework (selected documents) USA FDA CBER OCTG) CTGTAC Regulation Legislation: Public Health Service Act, sections 351 and 361 [42 USC 264] Regulations for Investigational New Drugs (IND), Code of Federal Regulations, Part 312 21 CFR 1271 * Human Cells, tissue, cellular- and tissue-based products 21 CFR 210 Current good manufacturing practice in manufacturing, processing, packaging or holding of drugs 21 CFR 211 Current good manufacturing practice for finished pharmaceuticals 21 CFR 600 Description of general safety and 21 CFR 610 sterility tests administered by parenteral routes (note, this is not a safety test of the product itself).