The U.S. Department of Health and Human Services has made Michael Davis, M.D., Ph.D., the permanent director of the FDA’s Center for Drug Evaluation and Research (CDER) and Karim Mikhail the permanent director of the Center for Biologics Evaluation and Research (CBER). Both had been serving in acting roles.
The appointments are intended to reduce uncertainty after extensive turnover in FDA leadership. They give the centers overseeing drugs, biologics, vaccines, blood products, and cell and gene therapies permanent leadership.
HHS also named Bret Koplow to lead the Center for Tobacco Products and Jared Seehafer as the FDA’s first deputy commissioner for technology and artificial intelligence.
FDA is still led on an interim basis by Kyle Diamantas. President Donald Trump has nominated White House aide Heidi Overton as permanent commissioner, but the Senate must confirm her.
The leadership changes may improve operational stability and provide sponsors with more predictable agency engagement, although the FDA’s longer-term priorities and review consistency could still shift after a permanent commissioner takes office.
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