The FDA laid out an approval framework for individualized gene-editing therapies aimed at single patients carrying specific disease-causing mutations. The agency described steps drugmakers can take to pursue regulatory approval for tailored gene-editing products, positioning the guidance as a structured route to bring precision medicines through development and review despite manufacturing and evidentiary challenges. For developers, the framework signals regulators are actively formalizing expectations for individualized approaches—an area that has outpaced conventional trial models and standard CMC planning timelines.