Navigating the Regulatory Landscape

CELL AND GENE THERAPY INSIGHTS

September 2015

Navigating the Regulatory Landscape

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Expert Insight

FDA resources for cell and gene therapy product development

FDA resources for cell and gene therapy product development

22 October 2015

Innovator Insight

A US Cell Therapy Regulatory Toolkit

A US Cell Therapy Regulatory Toolkit

E Culme-Seymour, J Lawford-Davies, M Carpenter et al.

13 September 2015

Regulatory Insight

Japan’s regulatory gamble and what it means for the Industry

Japan’s regulatory gamble and what it means for the Industry

Lee Buckler, Colin Novick

15 September 2015

Regulatory viewpoints on the development of advanced stem cell–based medicinal products in light of the first EU-approved stem cell product

Regulatory viewpoints on the development of advanced stem cell–based medicinal products in light of the first EU-approved stem cell product

E Flory, P Gasparini, P Celis et al.

15 September 2015

Japan’s regulatory framework: seeking to provide impetus to the commercialization of regenerative medicine products

Japan’s regulatory framework: seeking to provide impetus to the commercialization of regenerative medicine products

Shintaro Sengoku, Mitsuya Sakurai, Yoshimi Yashiro

15 September 2015