FDA Focuses on Individualized Gene Therapy Development, Issues Draft Guidance on BLA Submission and Postapproval Management for Individualized Human Genome Editing Products
November 4, 2026Policy & Regulation, Food and Drug Administration (FDA), Prescription Drugs, Life Sciences, Biologics, Drug Development
On October 27, 2026, the Food and Drug Administration (FDA) issued draft guidance on how to submit and manage a Biologics License Application (BLA) for individualized human genome editing (GE) products including multiple product variants. The draft guidance, Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management, is open for public comment until November 27, 2026.
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