The FDA issued draft guidance that would shape how sponsors pursue approvals for individualized human genome editing products for rare genetic diseases. The document, “Individualized Human Genome Editing Products: Considerations for BLA Submission and Postapproval Management” (FDA-2026-D-11783), lays out expectations for biologics license applications (BLAs) and postapproval management, including how to handle patient-specific variation. A key construct in the guidance is the Individualized Feature Space (IFS)—pre-defined limits that describe allowable variation for gene-editing components while keeping the program within scope of a single BLA. The FDA also describes example logic for individualized features such as allowable gRNA spacer sequences, including the concept of maintaining the same editing outcome. Regulators are soliciting public comments through Nov. 27. Investors and gene-editing companies are positioning the draft as a potential de-risking catalyst because it offers a more explicit regulatory pathway for personalized genome editing rather than requiring additional clinical trials for certain kinds of variation.