Vijay Kumar is stepping down as acting director of the FDA’s Office of Therapeutic Products within CBER, according to STAT and an FDA-related statement reviewed by the agency’s leadership team. Acting oversight will shift to CBER Director Karim Mikhail while the FDA advertises the permanent director role. The transition caps a year marked by turnover in CBER leadership, with Kumar previously promoted to the OTP acting role and succeeding earlier direction that had drawn criticism across the cell and gene therapy review pipeline. For sponsors and CROs, the change underscores the continued operational focus on review consistency and timeline discipline as the agency manages expanding cell and gene therapy volumes. Separately, regulatory scrutiny remains active beyond leadership changes: FDA actions and guidance continue to ripple across development and manufacturing expectations for advanced therapies and other biologics pathways.