FDA officials signaled support for a flexible, cautious regulatory approach to CAR‑T development for autoimmune diseases, urging long‑term follow‑up similar to genetic therapies used in oncology. Agency leaders recommended extended monitoring to assess potential late risks, including secondary malignancies and fertility impacts. The stance—expressed in agency commentary and amplified in a STAT+ analysis—sets expectations for sponsors to design trials with prolonged safety surveillance and robust post‑marketing follow‑up. The guidance reflects the agency’s balancing of therapeutic promise against safety uncertainties when applying potent cell therapies in non‑oncologic populations. Developers seeking to repurpose CAR‑T for autoimmune indications should prepare to include extended monitoring and registries, which could affect trial timelines, costs and post‑approval obligations.