An FDA perspective on preclinical development of cell-based regenerative medicine products

被引:57
作者
Bailey, Alexander M. [1 ]
Mendicino, Michael [1 ,2 ]
Au, Patrick [1 ]
机构
[1] US FDA, Ctr Biol Evaluat & Res, Off Cellular Tissue & Gene Therapies, Silver Spring, MD 20993 USA
[2] US FDA, Off Commissioner, Off Chief Scientist, Off Regulatory Sci & Innovat, Silver Spring, MD USA
关键词
D O I
10.1038/nbt.2971
中图分类号
Q81 [生物工程学(生物技术)]; Q93 [微生物学];
学科分类号
071005 [微生物学]; 090105 [作物生产系统与生态工程];
摘要
引用
收藏
页码:721 / 723
页数:3
相关论文
共 4 条
[1]
Anatol R, 2014, PRINCIPLES OF TISSUE ENGINEERING, 4TH EDITION, P1781, DOI 10.1016/B978-0-12-398358-9.00086-0
[2]
IS MY PRODUCT CAPABLE OF TUMOR FORMATION? [J].
Bailey, Alexander M. .
SCIENCE TRANSLATIONAL MEDICINE, 2012, 4 (147)
[3]
MSC-Based Product Characterization for Clinical Trials: An FDA Perspective [J].
Mendicino, Michael ;
Bailey, Alexander M. ;
Wonnacott, Keith ;
Puri, Raj K. ;
Bauer, Steven R. .
CELL STEM CELL, 2014, 14 (02) :141-+
[4]
Three Rs of Animal Testing for Regenerative Medicine Products [J].
Robinson, Rebecca .
SCIENCE TRANSLATIONAL MEDICINE, 2011, 3 (112)