Chapter title |
United States Food and Drug Administration Regulation of Gene and Cell Therapies
|
---|---|
Chapter number | 1 |
Book title |
Regulatory Aspects of Gene Therapy and Cell Therapy Products
|
Published in |
Advances in experimental medicine and biology, January 2015
|
DOI | 10.1007/978-3-319-18618-4_1 |
Pubmed ID | |
Book ISBNs |
978-3-31-918617-7, 978-3-31-918618-4
|
Authors |
Alexander M. Bailey, Judith Arcidiacono, Kimberly A. Benton, Zenobia Taraporewala, Steve Winitsky, Bailey, Alexander M., Arcidiacono, Judith, Benton, Kimberly A., Taraporewala, Zenobia, Winitsky, Steve |
Abstract |
The United States (US) Food and Drug Administration (FDA) is a regulatory agency that has oversight for a wide range of products entering the US market, including gene and cell therapies. The regulatory approach for these products is similar to other medical products within the United States and consists of a multitiered framework of statutes, regulations, and guidance documents. Within this framework, there is considerable flexibility which is necessary due to the biological and technical complexity of these products in general. This chapter provides an overview of the US FDA regulatory oversight of gene and cell therapy products. |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 26 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Master | 5 | 19% |
Researcher | 5 | 19% |
Student > Bachelor | 3 | 12% |
Student > Ph. D. Student | 3 | 12% |
Student > Doctoral Student | 1 | 4% |
Other | 3 | 12% |
Unknown | 6 | 23% |
Readers by discipline | Count | As % |
---|---|---|
Biochemistry, Genetics and Molecular Biology | 8 | 31% |
Pharmacology, Toxicology and Pharmaceutical Science | 2 | 8% |
Nursing and Health Professions | 2 | 8% |
Social Sciences | 2 | 8% |
Medicine and Dentistry | 2 | 8% |
Other | 3 | 12% |
Unknown | 7 | 27% |