New acting head Karim Mikhail seeks to steady FDA’s biologics center after turbulent leadership

Karim Mikhail, the acting director of the FDA’s Center for Biologics Evaluation and Research, told staff in a town‑hall meeting that he understands the pressures they face and wants to work alongside them.

He says his priority is to lift morale and review several controversial product rejections that occurred under his predecessor, Vinay Prasad, with an eye toward more consistent decision‑making.

Early actions include convening expert advisers, encouraging the submission of biologic applications, and signaling a more flexible approach to regulatory review, indicating a shift toward stability at the center.