Video Interview: A Regulatory Playbook for Gene Therapy

Gene therapy

In this video interview, Courtney Silverthorn from the Foundation for the National Institute’s of Health gives the story behind a new regulatory playbook for gene therapy.

The Bespoke Gene Therapy Consortium has published a regulatory playbook designed to serve as a “Guiding framework for the development and regulatory submission of adeno-associated virus gene therapies for rare diseases.” The playbook is free to access and draws upon publicly available resources, including FDA guidances and other official publications.

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