Development and regulation of cellular and gene therapy products [electronic resource] : FDA perspective / Larissa Lapteva.
Material type:
FilmSeries: Henry Stewart talksBiomedical & life sciences collection: Publisher: London : Henry Stewart Talks, 2021Description: 1 online resource (1 streaming video file (51 min.) : color, sound)Subject(s): United States Food and Drug Administration | Cellular therapy -- Law and legislation | Cellular therapy -- Moral and ethical aspects | Gene therapy -- Law and legislation | Gene therapy -- Moral and ethical aspects | Human genetics -- Government policy -- United States | Stem cells -- Therapeutic use | Cell- and Tissue-Based Therapy -- ethics | Cell- and Tissue-Based Therapy -- standards | Genetic Therapy -- ethics | Genetic Therapy -- legislation & jurisprudence | Genetic Therapy -- standards | United States Food and Drug AdministrationOnline resources: Click here to access online 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.
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Mode of access: World Wide Web.