Genome Editing: US FDA Eyes Platform-Based Approach To Development And Approval

CBER Director Peter Marks outlines a streamlined process to approval for treating different mutations of the same gene. NCATS’ Philip Brooks tells the Pink Sheet the approach avoids the need to “start from scratch for every new mutation.”

Diving platform
Genome editing poses special considerations for the platform approach to development and regulatory review. • Source: Shutterstock

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