The FDA issued draft guidance focused on individualized human genome editing products, setting out considerations for BLA submissions and postapproval management. A key element of the framework is the concept of the Individualized Feature Space (IFS), intended to define pre-approved limits on certain genome-edited components—such as variable gRNA spacer sequences—so sponsors can vary patients’ sequences without needing new clinical trials, while staying within a single BLA scope. The agency is soliciting public comment through November 27, and markets treated the guidance as a de-risking step for gene editing developers pursuing regulatory pathways for rare genetic diseases.