Overview of the Regulatory Oversight Implemented by the French Regulatory Authorities for the Clinical Investigation of Gene Therapy and Cell Therapy Products. [electronic resource]
- Advances in experimental medicine and biology 2015
- 73-85 p. digital
Publication Type: Journal Article; Review
0065-2598
10.1007/978-3-319-18618-4_4 doi
Animals Biological Products--therapeutic use Cell- and Tissue-Based Therapy--ethics Clinical Trials as Topic DNA, Recombinant--therapeutic use Drug Approval--legislation & jurisprudence Drug and Narcotic Control--legislation & jurisprudence France Genetic Therapy--ethics Genetic Vectors--therapeutic use Humans Investigational New Drug Application--legislation & jurisprudence Patient Safety--legislation & jurisprudence Practice Guidelines as Topic Research Design Translational Research, Biomedical--ethics