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Paving the Way for Precision Medicine: How the FDA's New Draft Guidance Accelerates Individualized Gene Editing

The U.S. Food and Drug Administration (FDA) recently released draft guidance titled “Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management.” The draft outlines considerations for Biologics License Application (BLA) submissions and postapproval management of patient-specific gene editing products, providing further guidance for the development and regulatory review of individualized gene editing therapies.