Senior FDA officials, including Vinay Prasad of CBER, published recommendations urging drug developers to conduct long‑term monitoring when using CAR‑T therapies to treat autoimmune conditions. The agency flagged theoretical risks—such as secondary malignancies and fertility effects—and recommended follow‑up periods analogous to genetic therapy standards used in oncology (often extending to 15 years). This guidance, issued in an Annals of Internal Medicine commentary, signals increased regulatory emphasis on extended safety surveillance for gene‑modifying immunotherapies in non‑oncology indications and will likely influence trial design, consenting, and postmarketing commitments.