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Regulatory development for gene and cell-therapies in the United States / Carolina Iglesias-Lopez.
- Format:
- Video
- Author/Creator:
- Iglesias-Lopez, Carolina, (Universitat Autònoma de Barcelona, Spain), 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--United States.
- Cellular therapy.
- Drug development--Law and legislation--United States.
- Drug development.
- Gene therapy--Law and legislation--United States.
- Gene therapy.
- Biological Products.
- Cell- and Tissue-Based Therapy--legislation & jurisprudence.
- Cell Engineering.
- Drug Development--legislation & jurisprudence.
- Genetic Therapy--legislation & jurisprudence.
- Legislation, Drug.
- United States. Food and Drug Administration.
- United States.
- Medical Subjects:
- Biological Products.
- Cell- and Tissue-Based Therapy--legislation & jurisprudence.
- Cell Engineering.
- Drug Development--legislation & jurisprudence.
- Genetic Therapy--legislation & jurisprudence.
- Legislation, Drug.
- Physical Description:
- 1 videorecording (25 min., 19 sec.) : sound, color
- Place of Publication:
- London : Henry Stewart Talks, 2023.
- System Details:
- video file
- Contents:
- Contents: US regulation of cell and gene therapies
- Gene therapies
- Cell-engineering
- Cell therapy
- Advanced therapies medicinal products (ATMP)
- Definition and classification of cell and gene therapies
- Drug regulatory affairs
- Biological drugs
- Drug development
- Clinical development
- Pre-IND meetings
- BLA review
- Special Protocol Assessment (SPA)
- Fast track, breakthrough and RMAT Designation.
- Notes:
- Description based on publisher supplied metadata and other sources.
- Animated audio-visual presentation with synchronized narration.
- Title from title frames.
- Publisher Number:
- 5758 Henry Stewart Talks
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