Vijay Kumar, acting director of the FDA’s Office of Therapeutic Products within CBER, is stepping down from the role after a year, according to reports citing an email statement. FDA leadership said acting CBER Director Karim Mikhail will oversee OTP during the transition, with plans to advertise the permanent director position. The change follows a broader period of turnover and debate inside CBER, where gene and cell therapy oversight has been scrutinized for consistency and review timelines. Kumar’s departure adds another adjustment point for sponsors who rely on predictable regulatory engagement and guidance. For the cell and gene therapy market, leadership continuity and approach can materially affect how companies plan pre-submission meetings, CMC packages, and registrational strategies.