Midthun Named Permanent CBER Director as New Safety Effort Launched

Karen Midthun has been named the permanent director of CBER and will lead the center as it launches a new effort to improve the safety of biologics and plays a key role in developing a new regulatory path for biosimilars. The promotion ends Midthun’s run as acting director, a position she took on last March. As part of the new biologics safety effort, CBER has created three safety teams that will gather data throughout the lifecycle of products regulated by the center. The agency hopes the teams will identify emerging safety issues more quickly and improve how they are communicated to the public, Robert Yetter, CBER’s associate director for review management, said.
Drug Industry Daily