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Cell & Gene Therapy
INSIGHTS
Regulatory Insights April 2022
April 2022
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Current global regulatory landscape for biodistribution & shedding assessment of rAAV gene therapies & recommendations of the IMI ARDAT consortium on future directions
N Schmidt,
J Giblin,
T MacLachlan
et al.
24 April 2022
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Unproven stem cell-based interventions & harm to existing & future patients
F Naylor,
K Matthews
27 March 2022
Editorial
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Previous reports
Regulatory Insights December 2021
FEATURING
EDITORIAL:
Cell and gene therapy approvals soar in the first half of 2021
C Bravery
PERSPECTIVE:
Demonstrating Comparability of AAV Gene Therapy Products During Clinical Development: Managing the Link Between the Product and the Process
N Kinsella,
C Blue
INTERVIEW:
US FDA perspective: getting back into high gear – driving cell and gene therapy forward through 2022 and beyond
P Marks
Read more
Regulatory Insights September 2021
FEATURING
PERSPECTIVE:
Clinical trials with investigational medicinal products consisting of or containing genetically modified organisms: implementation of Clinical Trials Regulation EU 536/2014
N Lambot,
J Awigena-Cook,
T Reimer
et al.
COMMENTARY:
The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies
E Bicudo,
I Brass,
P Carmichael
et al.
Read more
Regulatory Insights June 2021
FEATURING
INTERVIEW:
Regulatory CMC in cell and gene therapy: navigating an evolving space
L Starke
Read more
Regulatory Insights March 2021
FEATURING
PERSPECTIVE:
Current status and future perspective of gene therapy products in Japan
Y Maruyama,
A Sakurai,
M Kasai
et al.
INTERVIEW:
Examining Health Canada’s agile new approach to regulating Advanced Therapeutic Products
E Toller,
L Gillham-Eisen,
N Kolas
Read more
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