TY - ADVS AU - Lapteva,Larissa TI - Development and regulation of cellular and gene therapy products: FDA perspective T2 - The biomedical & life sciences collection, PY - 2021/// CY - London PB - Henry Stewart Talks KW - United States KW - Food and Drug Administration KW - Cellular therapy KW - Law and legislation KW - Moral and ethical aspects KW - Gene therapy KW - Human genetics KW - Government policy KW - Stem cells KW - Therapeutic use KW - Cell- and Tissue-Based Therapy KW - ethics KW - standards KW - Genetic Therapy KW - legislation & jurisprudence KW - United States Food and Drug Administration N1 - Animated audio-visual presentation with synchronized narration; Title from title frames; Contents: Cellular and gene therapy products -- U.S. laws and regulations -- FDA review -- Product development considerations -- Regulatory considerations -- Product manufacturing stages and quality testing -- Safety, efficacy and ethical considerations for clinical program design -- FDA Guidance documents; Access restricted to subscribers UR - https://hstalks.com/bs/4793/ ER -