FDA gene and cell therapy review office loses acting director Vijay Kumar

Vijay Kumar has announced he will step down from his role as acting director of the Office of Gene and Cell Therapy Reviews within the FDA's Center for Biologics Evaluation and Research.

Karim Mikhail, who is currently serving as acting CBER director, will also assume the acting director position for the Office of Therapeutic Products to keep regulatory work moving while the agency looks for a permanent appointee.

The move follows a series of recent leadership changes at the FDA, including the resignations of former Commissioner Marty Makary and CBER Director Vinay Prasad, as well as the dismissal of Tracy Beth Høeg from the Center for Drug Evaluation and Research.

These shifts leave many senior roles occupied by temporary officials, creating uncertainty about long‑term staffing and continuity in the agency's oversight of advanced therapies.