Re-examination of regulatory opinions in Europe: possible contribution for the approval of the first gene therapy product Glybera

por Watanabe, Natsumi, Yano, Kazuo, Tsuyuki, Kenichiro, Okano, Teruo, Yamato, Masayuki
Publicado 2015

Compassionate use of drugs and medical devices in the United States, the European Union and Japan

por Tsuyuki, Kenichiro, Yano, Kazuo, Watanabe, Natsumi, Aruga, Atsushi, Yamato, Masayuki
Publicado 2016

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

por Yano, Kazuo, Watanabe, Natsumi, Tsuyuki, Kenichiro, Ikawa, Taisuke, Kasanuki, Hiroshi, Yamato, Masayuki
Publicado 2014