Lapteva, Larissa,
Development and regulation of cellular and gene therapy products FDA perspective / [electronic resource] : Larissa Lapteva. - London : Henry Stewart Talks, 2021. - 1 online resource (1 streaming video file (51 min.) : color, sound). - The biomedical & life sciences collection, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. .
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.
Mode of access: World Wide Web.
5636 Henry Stewart Talks
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 Administration.
Development and regulation of cellular and gene therapy products FDA perspective / [electronic resource] : Larissa Lapteva. - London : Henry Stewart Talks, 2021. - 1 online resource (1 streaming video file (51 min.) : color, sound). - The biomedical & life sciences collection, 2056-452X . - Henry Stewart talks. Biomedical & life sciences collection. .
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.
Mode of access: World Wide Web.
5636 Henry Stewart Talks
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 Administration.