Federal Register #2026-21954

FDA Draft Guidance for Individualized Human Genome Editing Products and BLA Submissions

The U.S. Food and Drug Administration (FDA), within the Department of Health and Human Services (HHS), has issued draft guidance for individualized human genome editing products. - Notice type: Draft guidance; this is not a procurement opportunity or award. - Government buyer: FDA, HHS. No specific sub-agency or office is identified. - Guidance topics: Submitting multiple product variants in one Biologics License Application (BLA), describing differences in genome-editing components, and adding variants after licensure. - Other requirements addressed: Potency and safety evaluation, manufacturing process validation, labeling and indications, and product naming and identification. - OEMs, vendors, products, and quantities: None identified; no goods or services are being solicited for purchase. - Performance period and contract value: Not applicable to this guidance notice.

Description

The FDA announces the availability of draft guidance for sponsors and applicants developing individualized human genome editing products. It provides recommendations for submitting a product with multiple variants in a single Biologics License Application (BLA). Topics include specifying the extent of component variation, adding variants after licensure, potency and safety evaluation, manufacturing process validation, labeling, and product naming and identification. Comments on the draft guidance are due November 27, 2026.

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