A decade of marketing approval of gene and cell-based therapies in the United States, European Union and Japan: An evaluation of regulatory decision-making

Author(s):
Coppens, D.G.M.; Wilde, S. de; Guchelaar, H.J. (0000-0002-7085-1383); Bruin, M.L. de; Leufkens, H.G.M.; Meij, P.; Hoekman, J.
Published
2018
Publication type
Article / Letter to editor
adaptive pathwaysbenefit/risk assessmentchimeric antigen receptor-T celldrug regulatory scienceexpedited pathwaysgene and cell-based therapieslife cycle approachmarketing approvalorphan drug designationpost-marketing risk management
Date issued
2018-06-30
Language
English
Is part of
Cytotherapy (2018), Vol. 20, no. 6, p. 769-778
hdl
1887/95568
doi
10.1016/j.jcyt.2018.03.038