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Development and regulation of cellular and gene therapy products : FDA perspective / Larissa Lapteva.
- Format:
- Video
- Author/Creator:
- Lapteva, Larissa, (Center for Biologics Evaluation and Research, FDA, USA), Speaker.
- Series:
- Henry Stewart talks. Biomedical & life sciences collection.
- The biomedical & life sciences collection, 2056-452X
- Language:
- English
- Subjects (All):
- Cellular therapy--Law and legislation.
- Cellular therapy.
- Cellular therapy--Moral and ethical aspects.
- Gene therapy--Law and legislation.
- Gene therapy.
- Gene therapy--Moral and ethical aspects.
- Human genetics--Government policy--United States.
- Human genetics.
- Stem cells--Therapeutic use.
- Stem cells.
- 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.
- United States.
- Medical Subjects:
- 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.
- Physical Description:
- 1 online resource (1 streaming video file (51 min.)) : sound, color
- Place of Publication:
- London : Henry Stewart Talks, 2021.
- System Details:
- video file
- Contents:
- 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.
- Notes:
- Description based on publisher supplied metadata and other sources.
- Animated audio-visual presentation with synchronized narration.
- Title from title frames.
- Publisher Number:
- 5636 Henry Stewart Talks
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