Regulation of Regenerative Medicine Products

被引：6
作者：
Gee, Adrian P. [1 ]
机构：
[1] Baylor Coll Med, CGMP Facil, Ctr Cell & Gene Therapy, Houston, TX 77030 USA
来源：
CARDIAC EXTRACELLULAR MATRIX: FUNDAMENTAL SCIENCE TO CLINICAL APPLICATIONS | 2018年 / 1098卷
关键词：
Extracellular matrix; Regenerative medicine; Cellular therapies; Regulatory authority; Food and Drug Administration; FDA guidance; GDraft guidance; Good manufacturing practices; GMP manufacturing; Investigational new drug application; Minimally manipulated; More than minimally manipulated;
D O I：
10.1007/978-3-319-97421-7_10
中图分类号：
Q5 [生物化学]; Q7 [分子生物学];
学科分类号：
071010 ; 081704 ;
摘要：
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.
引用
收藏
页码：189 / 198
页数：10
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