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United States Food and Drug Administration Regulation of Gene and Cell Therapies.
Adv Exp Med Biol. 2015; 871:1-29.AE

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.

Authors+Show Affiliations

Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA. alexander.bailey@fda.hhs.gov.Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.Office of Cellular, Tissue, and Gene Therapies (OCTGT), Center for Biologics Evaluation and Research (CBER), United States Food and Drug Administration, 10903 New Hampshire Avenue, Silver Spring, MD, 20993, USA.

Pub Type(s)

Journal Article
Review

Language

eng

PubMed ID

26374210

Citation

Bailey, Alexander M., et al. "United States Food and Drug Administration Regulation of Gene and Cell Therapies." Advances in Experimental Medicine and Biology, vol. 871, 2015, pp. 1-29.
Bailey AM, Arcidiacono J, Benton KA, et al. United States Food and Drug Administration Regulation of Gene and Cell Therapies. Adv Exp Med Biol. 2015;871:1-29.
Bailey, A. M., Arcidiacono, J., Benton, K. A., Taraporewala, Z., & Winitsky, S. (2015). United States Food and Drug Administration Regulation of Gene and Cell Therapies. Advances in Experimental Medicine and Biology, 871, 1-29. https://doi.org/10.1007/978-3-319-18618-4_1
Bailey AM, et al. United States Food and Drug Administration Regulation of Gene and Cell Therapies. Adv Exp Med Biol. 2015;871:1-29. PubMed PMID: 26374210.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - United States Food and Drug Administration Regulation of Gene and Cell Therapies. AU - Bailey,Alexander M, AU - Arcidiacono,Judith, AU - Benton,Kimberly A, AU - Taraporewala,Zenobia, AU - Winitsky,Steve, PY - 2015/9/17/entrez PY - 2015/9/17/pubmed PY - 2015/12/30/medline KW - Cell therapy KW - Clinical development KW - Clinical trial KW - Gene therapy KW - Marketing application KW - Product licensure KW - Public health KW - US Food and Drug Administration (US FDA) SP - 1 EP - 29 JF - Advances in experimental medicine and biology JO - Adv. Exp. Med. Biol. VL - 871 N2 - 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. SN - 0065-2598 UR - https://www.unboundmedicine.com/medline/citation/26374210/United_States_Food_and_Drug_Administration_Regulation_of_Gene_and_Cell_Therapies_ L2 - https://dx.doi.org/10.1007/978-3-319-18618-4_1 DB - PRIME DP - Unbound Medicine ER -