Under a new leader, the FDA's biologics center moves to steady itself after stormy chapter

With meetings of expert advisers and acceptance of drug submissions, CBER is showing renewed flexibility

Karim Mikhail (left) and Vinay Prasad have each led the FDA’s Center for Biologics Evaluation and Research.Camille MacMillin/STAT

Lizzy leads STAT’s coverage of the FDA. Her stories explore the relationship between politics and science at the FDA, industry influence, and the agency’s ability to protect and promote public health. Confidential tips can be sent on Signal at lizzylaw.53.

In a recent town hall meeting, Karim Mikhail told Food and Drug Administration staff that he was normal.

“I am with you on planet Earth,” he said in June. “I understand very well what everybody is going through.”