Global Update on the Cell & Gene Therapy Regulatory Landscape

CELL AND GENE THERAPY INSIGHTS

Global Update on the Cell & Gene Therapy Regulatory Landscape

June 2018
Global Update on the Cell & Gene Therapy Regulatory Landscape
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Editorial

New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?

New Gene Therapy CMC Guidance from the FDA – A Breakthrough in Regulation or Something More Generic?

Anthony H Davies
15 August 2018
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Expert Insight

Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective

Accelerated Access of Advanced Regenerative Therapies: an Industry Perspective

Yaron Ramati
6 August 2018
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Breakthrough Therapy Designation & Regenerative Medicine Advanced Therapy Designation Programs in Cellular & Gene Therapies

Breakthrough Therapy Designation & Regenerative Medicine Advanced Therapy Designation Programs in Cellular & Gene Therapies

Xiaofei Wang, Wilson W Bryan, Lei Xu
30 July 2018
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The Regulatory Environment for Cell Therapies in Australia – an Opportunity to Expedite Clinical Development

The Regulatory Environment for Cell Therapies in Australia – an Opportunity to Expedite Clinical Development

Simon Bishop, Simone Flight, Natalie Thomas
30 July 2018
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Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products

Experiences from Japan – SAKIGAKE Designation System for Regenerative Medical Products

Y Maruyama, M Kasai, K Oyama et al.
17 July 2018
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Proposed Solutions to Further Improve the Regulatory Landscape for ATMPs in Europe

Proposed Solutions to Further Improve the Regulatory Landscape for ATMPs in Europe

A Hubert, J Barry, C Vieira et al.
17 July 2018
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