Regulatory approval for autologous human cells and tissue products in the United States, the European Union, and Japan

Lignende værker

• Compassionate use of drugs and medical devices in the United States, the European Union and Japan
  af: Tsuyuki, Kenichiro, et al.
  Udgivet: (2016)
• Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera
  af: Watanabe, Natsumi, et al.
  Udgivet: (2015)
• Non-clinical assessment design of autologous chondrocyte implantation products
  af: Ikawa, Taisuke, et al.
  Udgivet: (2015)
• Bayesian statistics and clinical trial designs for human cells and tissue products for regulatory approval
  af: Jokura, Yoji, et al.
  Udgivet: (2016)
• Expedited approval system for regenerative medicine products – Is it unusual?
  af: Yano, Kazuo, et al.
  Udgivet: (2016)