Researchers behind the bespoke CRISPR therapy for 'Baby KJ' published detailed FDA interactions and are engaging regulators to formalize a pathway for bespoke gene‑editing treatments. The team presented the rapid development, multi‑institution collaboration and regulatory exchanges used to create a one‑patient therapeutic that corrected a rare mutation. Investigators say the lessons could enable a reproducible framework for individualized genomic medicines, balancing speed with safety and potential reimbursement models. The work highlights practical regulatory questions—manufacturing controls, preclinical evidence thresholds, and long‑term follow‑up—that sponsors and the FDA must address to scale personalized gene‑editing solutions.