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FDA (CBER)
GUIDANCE DRAFT
Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management
Published: 10/27/2026Detected: 10/27/2026

Summary preview

Provides draft FDA CBER guidance on how sponsors of individualized human genome editing products should structure BLA submissions and plan for postapproval management.

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manufacturing
quality
clinical
safety
labeling
#CBER
#BLA submission
#individualized therapy
#human genome editing
#CMC

Official Source Document
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