Regulatory Insights April 2022
April 2022
Previous reports
Regulatory Insights December 2021
FEATURING
EDITORIAL:
Cell and gene therapy approvals soar in the first half of 2021
PERSPECTIVE:
Demonstrating Comparability of AAV Gene Therapy Products During Clinical Development: Managing the Link Between the Product and the Process
INTERVIEW:
US FDA perspective: getting back into high gear – driving cell and gene therapy forward through 2022 and beyond
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
COMMENTARY:
The UK’s emerging regulatory framework for point-of-care manufacture: insights from a workshop on advanced therapies
