FDA Appoints Katherine Szarama as Acting CBER Director Amid Leadership Changes
The U.S. Food and Drug Administration (FDA) has appointed Katherine Szarama as the acting director of the Center for Biologics Evaluation and Research (CBER). Szarama, who previously served as deputy under Vinay Prasad, steps into the role following Prasad's departure. Prasad's tenure was marked by controversy, particularly surrounding the handling of Sarepta Therapeutics' Elevidys, a gene therapy for Duchenne muscular dystrophy, which faced shipment halts after patient deaths. Szarama's background includes roles at the Centers for Medicare and Medicaid Services and the Advanced Research Projects Agency for Health. Her appointment is part of a broader pattern of temporary leadership within the Department of Health and Human Services (HHS), as the agency navigates ongoing challenges and transitions.