The Next Phase of Human Gene-Therapy Oversight

被引：65
作者：
Collins, Francis S. [1 ]
Gottlieb, Scott [2 ]
机构：
[1] NIH, Bldg 10, Bethesda, MD 20892 USA
[2] US FDA, Silver Spring, MD USA
来源：
NEW ENGLAND JOURNAL OF MEDICINE | 2018年 / 379卷 / 15期
基金：
美国国家卫生研究院;
关键词：
D O I：
10.1056/NEJMp1810628
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
As gene therapy continues to change, so must the federal framework set up to oversee it. As new biotechnologies continue to emerge, the NIH and the FDA are proposing reductions in duplicative oversight and changes to the role of the Recombinant DNA Advisory Committee. © 2018 Massachusetts Medical Society. All rights reserved.
引用
收藏
页码：1393 / 1395
页数：3
相关论文
共 5 条
  • [1] Applications of CRISPR technologies in research and beyond
    Barrangou, Rodolphe
    Doudna, Jennifer A.
    [J]. NATURE BIOTECHNOLOGY, 2016, 34 (09) : 933 - 941
  • [2] Lenzi RN, 2014, OVERSIGHT REV CLIN G, DOI [10.17226/18577, DOI 10.17226/18577]
  • [3] Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia
    Maude, S. L.
    Laetsch, T. W.
    Buechner, J.
    Rives, S.
    Boyer, M.
    Bittencourt, H.
    Bader, P.
    Verneris, M. R.
    Stefanski, H. E.
    Myers, G. D.
    Qayed, M.
    De Moerloose, B.
    Hiramatsu, H.
    Schlis, K.
    Davis, K. L.
    Martin, P. L.
    Nemecek, E. R.
    Yanik, G. A.
    Peters, C.
    Baruchel, A.
    Boissel, N.
    Mechinaud, F.
    Balduzzi, A.
    Krueger, J.
    June, C. H.
    Levine, B. L.
    Wood, P.
    Taran, T.
    Leung, M.
    Mueller, K. T.
    Zhang, Y.
    Sen, K.
    Lebwohl, D.
    Pulsipher, M. A.
    Grupp, S. A.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (05) : 439 - 448
  • [4] Gene therapy: Trials and tribulations
    Somia, N
    Verma, IM
    [J]. NATURE REVIEWS GENETICS, 2000, 1 (02) : 91 - 99
  • [5] U. S. Food and Drug Administration, CELL GEN THER GUID V
1