Steve Winitsky
VP, Technical, Regulatory Strategy at Parexel
Best podcasts with Steve Winitsky
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Mar 1, 2024 • 34min
CAR-T boxed warnings: What comes next?
The podcast discusses FDA's new boxed warning for CAR-T therapies due to secondary T-cell cancers. Regulatory experts explain implications for developers. Topics include rationale, classwide warnings, monitoring requirements, and considerations for non-life-threatening conditions.
