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Abstract
A preclinical study on a gene therapy approach for treatment of the severe muscle weakness associated with a variety of neuromuscular disorders provides a forum to discuss the translational challenges of gene therapy from a regulatory point of view. In this Perspective, the findings are considered from the view of European regulatory requirements for first clinical use.
Footnotes
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Citation: M. C. Galli, Regulatory Considerations for Translating Gene Therapy: A European Union Perspective. Sci. Transl. Med. 1, 6ps6 (2009).
- Copyright © 2009, American Association for the Advancement of Science
