Regulatory development for gene and cell-therapies in the United States
| Main Author: | |
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| Format: | eBook |
| Language: | English |
| Published: |
London
Henry Stewart Talks
2023, 2023
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| Series: | The biomedical & life sciences collection
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| Subjects: | |
| Online Access: | |
| Collection: | Henry Stewart Talks - Collection details see MPG.ReNa |
Table of 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