FDA Leadership Shakeup: Szarama Replaced as Acting CBER Director Amidst Agency Cleanout
Katherine Szarama, who was appointed as the acting director of the Center for Biologics Evaluation and Research (CBER) at the FDA, has been replaced by Karim Mikhail after less than three weeks in the role. Szarama, an ally of former biologics chief Vinay Prasad, is reportedly transitioning to a different capacity within the FDA, although some reports suggest she may be leaving the agency entirely. Mikhail, who has a long history in the pharmaceutical industry, including over two decades at Merck and a recent tenure as President and CEO of Amarin Corporation, will serve as the acting head of CBER while the FDA searches for a permanent director. This change is part of a broader leadership overhaul at the FDA, which has seen several high-profile exits, including former Commissioner Marty Makary and acting director of the Center for Drugs Evaluation and Research, Tracy Beth Høeg. 
