The FDA announced an approval framework intended to help sponsors pursue gene editing medicines tailored to individual patients with single disease-causing mutations. The agency outlined steps drugmakers can follow to seek regulatory approval for these individualized programs, positioning guidance as a practical regulatory blueprint for precision gene editing. For cell and gene therapy developers, the announcement matters because patient-specific designs stress traditional clinical evidence norms, manufacturing variability, and long-term follow-up planning. The FDA’s process-focused guidance is expected to influence trial architecture and documentation for future individualized editing submissions.