STAT+: Under a new leader, the FDA’s biologics center moves to steady itself after stormy chapter

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.” 

Typically, such an acknowledgment would be unremarkable. But Mikhail is acting director of the FDA’s Center for Biologics Evaluation and Research, where the previous leader, Vinay Prasad, was decidedly outside the norm.

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