September 09, 2026
Karim Mikhail, B. Pharm, MSc, has been selected to serve as director of the FDA's Center for Biologics Evaluation and Research (CBER) after serving as the center's acting director, the Department of Health and Human Services announced Tuesday.
Mikhail brings more than two decades of leadership experience across the pharmaceutical and biotechnology sectors and FDA. Since joining the agency, he has worked on initiatives to strengthen U.S. competitiveness, accelerate clinical development and expand domestic biopharmaceutical manufacturing.
He succeeds Vinay Prasad, MD, MPH, who departed the agency in April.