Harpreet Singh
Chief Medical Officer at Precision for Medicine and former FDA Division Director of Oncology, providing expert perspective on CAR-T regulation and drug development.
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Feb 27, 2026 • 23min
Autoimmune CAR-T: Navigating the FDA’s new regulatory playbook
Harpreet Singh, Chief Medical Officer at Precision for Medicine and former FDA oncology division director, discusses CAR-T moving into autoimmune diseases. He unpacks the FDA’s cautious, case-by-case regulatory stance. Topics include long-term safety and follow-up, evolving clinical endpoints, reproductive and pediatric concerns, and which autoimmune settings may be best suited for CAR-T.
