HHS locks in CBER, CDER leadership

The U.S. Department of Health and Human Services announced the selection of permanent CBER and CDER directors, in what the agency is calling a “deliberate strategy to drive innovation and meaningful reform across FDA.”

Karim Mikhail, B.Pharm, MSc, has been selected to serve as director of CBER after serving as the center’s acting director. Prior to joining the FDA in 2025, Mikhail spent over two decades in the private pharma industry, including serving as the CEO of Amarin.

In May 2026, Katherine Szarama, who had stepped in as CBER acting director following the controversial departure of Dr. Vinay Prasad, ceased her duties at CBER. Mikhail took over as acting director.

Dr. Michael Davis, MD, Ph.D., has been selected to serve as director of CDER after serving as the center’s acting director and previously as its deputy center director. According to HHS, Davis will direct CDER's agenda with a focus on three critical areas: increasing patient access to safe and affordable critical medicines, advancing the science of drug development and evaluation, and strengthening the domestic and global drug supply chain.

Days after FDA commissioner Marty Makary’s resigned in May 2026, Tracy Beth Høeg, acting director of CDER, was fired. Høeg announced her dismissal via a post on X, Davis took over in an acting capacity.

In addition to the CDER and CBER appointments, Jared Seehafer will serve as the FDA’s direct deputy commissioner for technology and AI, providing leadership in establishing FDA-wide strategy and priorities. Bret Koplow, Ph.D., will serve as director of the center for tobacco products, after serving as the center’s acting director.