FDA solidifies CDER, CBER leadership posts as commissioner confirmation awaits

Pharma FDA solidifies CDER, CBER leadership posts as commissioner confirmation awaits By Fraiser Kansteiner Sep 9, 2026 9:00am U.S. FDA CBER CDER Donald Trump Following a monthslong interregnum at the U.S. Food and Drug Administration, the leadership pieces are again locking into place at the regulator.

In a stabilizing move, the Department of Health and Human Services announced Tuesday afternoon that it has tapped Michael Davis, M.D., Ph.D., and Karim Mikhail—who’ve been serving as acting directors of the Centers for Drugs Evaluation and Research (CDER) and the Centers for Biologics Evaluation and Research (CBER), respectively—to occupy their posts on a permanent basis. Rather than just filling vacancies, the selections “signal the direction we are heading,” acting FDA commissioner Kyle Diamantas said in a Sept. 8 statement.

“These leaders will help us attract and retain best-in-class talent while building the workforce and infrastructure needed to accelerate innovative across all FDA centers.” While Diamantas serves as FDA chief on an interim basis, President Trump last month announced Heidi Overton, M.D., Ph.D.—currently a White House aide—as his pick to fill the vacancy permanently. Overton, who previously directed the MAHA-aligned Center for a Healthy America and received degrees from the New Mexico School of Medicine and Johns Hopkins University Bloomberg School of Public Health, must still face the Senate before she is confirmed. Still, Overton’s nomination and the solidification of Davis’ and Mikhail’s roles has the potential to calm a turbulent patch at the agency, which began with the Trump administration’s return to the White House early last year and arguably culminated in previous commissioner Martin Makary, M.D., announcing his departure in May.

Commissioner post aside, the leadership roles over CBER and CDER, which broadly oversee the regulation of biologics and vaccines and small molecule drugs, respectively, have also been thrown into disarray, with the departure of longtime, respected staffers like Patrizia Cavazzoni, M.D. (CDER), Richard Pazdur, M.D. (CDER) and Peter Marks, M.D., Ph.D.

(CBER), ultimately giving way to the arrival of a string of more controversial—and short-tenured—leaders. Still, Davis and Mikhail appear more closely aligned with the sort of experience that the industry has traditionally valued in its regulatory chiefs. Davis, overseeing CDER, has held a number of other positions at the FDA, including in leadership posts at CDER’s Office of New Drugs.

A psychiatrist and pharmacologist by training, he was also formerly the chief medical officer at non-profit psychedelic drug developer Usona Institute, according to his LinkedIn profile. For his part, Mikhail—now in charge of CBER—previously served as president and CEO at Amarin, and he also held a string of leadership positions over a 22-year stint at Merck & Co. Apart from the HHS announcement, the FDA’s official leadership page has now been updated to reflect the changes.

Meanwhile, joining Davis and Mikhail in their roles will be Jared Seehafer, now the FDA’s first ever deputy commissioner for technology and artificial intelligence, and Bret Koplow, Ph.D., who will direct the Center for Tobacco Products. Seehafer’s new post “underscores the Trump Administration’s commitment to accelerating reliable AI innovation, modernizing federal technology, and ensuring an effective regulatory framework for emerging technologies,” HHS said in its release. In late August, reports surfaced that the FDA was considering creating new deputy posts under the commissioner, both around artificial intelligence and drugs regulation, according to CNBC, citing sources familiar with the plan.

At the time, the news service added a caveat that no final determinations had been made about the roles. U.S. FDA CBER CDER Donald Trump regulatory Chutes and Ladders United States Karim Mikhail Pharma