FDA Oversight of Cell Therapy Clinical Trials

被引:28
|
作者
Au, Patrick [1 ]
Hursh, Deborah A. [1 ]
Lim, Agnes [1 ]
Moos, Malcolm C., Jr. [1 ]
Oh, Steven S. [1 ]
Schneider, Bruce S. [1 ]
Witten, Celia M. [1 ]
机构
[1] US FDA, Off Cellular Tissue & Gene Therapies, Ctr Biol Evaluat & Res, Rockville, MD 20852 USA
关键词
D O I
10.1126/scitranslmed.3004131
中图分类号
Q2 [细胞生物学];
学科分类号
071009 ; 090102 ;
摘要
引用
收藏
页数:3
相关论文
共 50 条
  • [21] Clinical research - FDA halts all gene therapy trials at Penn
    Marshall, E
    SCIENCE, 2000, 287 (5453) : 565 - +
  • [22] FDA, European Drug Agency Collaborate on Clinical Trial Oversight
    不详
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2009, 302 (16): : 1740 - 1740
  • [23] As Use of Foreign Drug Trials Grows, FDA Oversight May Not Be Keeping Up
    Mitka, Mike
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2010, 304 (08): : 843 - 844
  • [24] Cell Genesys clears FDA for expanded AIDS gene therapy trials
    不详
    DRUG NEWS & PERSPECTIVES, 1996, 9 (04) : 252 - 252
  • [25] US tightens oversight of gene-therapy trials
    McCarthy, M
    LANCET, 2000, 355 (9208): : 997 - 997
  • [26] Therapy and clinical trials: Clinical therapy and trials
    Chudleigh, R
    Platts, J
    CURRENT OPINION IN LIPIDOLOGY, 2004, 15 (06) : 711 - 714
  • [27] FDA Oversight of Postmarketing Studies
    Kashoki, Mwango
    Lee, Cathryn
    Stein, Peter
    NEW ENGLAND JOURNAL OF MEDICINE, 2017, 377 (12): : 1201 - 1202
  • [28] FDA leery of tobacco oversight
    Mitka, Mike
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2007, 298 (18): : 2129 - 2129
  • [29] FDA and Mobile App Oversight
    不详
    JOURNAL OF NUCLEAR MEDICINE, 2011, 52 (09) : 25N - 25N
  • [30] Harmonization and streamlining of research oversight for pragmatic clinical trials
    O'Rourke, P. Pearl
    Carrithers, Judith
    Patrick-Lake, Bray
    Rice, Todd W.
    Corsmo, Jeremy
    Hart, Raffaella
    Drezner, Marc K.
    Lantos, John D.
    CLINICAL TRIALS, 2015, 12 (05) : 449 - 456