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Regulation of Regenerative Medicine Products.
- Source :
-
Advances in experimental medicine and biology [Adv Exp Med Biol] 2018; Vol. 1098, pp. 189-198. - Publication Year :
- 2018
-
Abstract
- Cellular therapies have moved to the forefront based upon promising results from clinical trials using both chimeric antigen receptor T lymphocytes to treat leukemia and other cell types to restore structure and function to tissues that have been damaged by disease or physical injury. The pace at which these treatments have evolved has posed a regulatory challenge to agencies, such as the Food and Drug Administration (FDA). This chapter describes how a specific regulatory strategy was developed and how it has evolved in response to the demand for these new therapies.
- Subjects :
- Animals
Cell- and Tissue-Based Therapy methods
Humans
Investigational New Drug Application
Public Policy trends
Regenerative Medicine methods
Regenerative Medicine standards
Risk Assessment
Tissue Engineering methods
Tissue Engineering standards
United States
United States Food and Drug Administration
Biological Products standards
Cell- and Tissue-Based Therapy standards
Extracellular Matrix
Regenerative Medicine legislation & jurisprudence
Tissue Engineering legislation & jurisprudence
Subjects
Details
- Language :
- English
- ISSN :
- 0065-2598
- Volume :
- 1098
- Database :
- MEDLINE
- Journal :
- Advances in experimental medicine and biology
- Publication Type :
- Academic Journal
- Accession number :
- 30238372
- Full Text :
- https://doi.org/10.1007/978-3-319-97421-7_10