The U.S. Department of Health and Human Services (HHS) has announced four senior leadership selections at the U.S. Food and Drug Administration (FDA), including new directors of two centers central to the regulation of drugs and biologic therapies.
Announced on September 8, 2026, the selections include Jared Seehafer, M.S., as FDA’s first Deputy Commissioner for Technology and Artificial Intelligence; Michael Davis, M.D., Ph.D., as Director of the Center for Drug Evaluation and Research (CDER); Karim Mikhail, B.Pharm., MSc, as Director of the Center for Biologics Evaluation and Research (CBER); and Bret Koplow, Ph.D., J.D., as Director of the Center for Tobacco Products (CTP).
HHS said the leadership appointments are part of efforts to advance innovation, strengthen national health security, increase access to medicines and medical products, and modernize the FDA’s approach to emerging technologies.
HHS Secretary Robert F. Kennedy Jr. said:
“We are building an FDA that moves faster, demands excellence, and delivers results for the American people. These leaders will drive the reforms needed to confront our nation’s most serious health challenges and strengthen American leadership in medical innovation.”
FDA Acting Commissioner Kyle Diamantas, J.D., added that the selections “are not just about filling leadership roles; they signal the direction we are heading.”
Jared Seehafer: Deputy Commissioner for Technology and Artificial Intelligence
Jared Seehafer, M.S., has been selected as the FDA’s first Deputy Commissioner for Technology and Artificial Intelligence, a newly created position. He will serve as the agency’s senior leader for technology, software, and AI and will help establish FDA-wide strategy and priorities in these areas.
Seehafer brings approximately two decades of technical and leadership experience at the intersection of software, artificial intelligence, and FDA-regulated medical technology.
Michael Davis: Director of CDER
Michael Davis, M.D., Ph.D., has been selected as Director of the Center for Drug Evaluation and Research (CDER) after serving as the center’s Acting Director and previously as Deputy Center Director.
During his FDA career, Davis has held leadership positions within CDER’s Office of New Drugs and has led multidisciplinary teams involved in drug review, regulatory science, and policy development.
As CDER Director, he will lead the center responsible for the evaluation and regulation of drugs in the United States, with priorities including access to critical medicines, advancing drug development and evaluation, and strengthening domestic and global drug supply chains.
Karim Mikhail: Director of CBER
Karim Mikhail, B.Pharm., MSc, has been selected as Director of the Center for Biologics Evaluation and Research (CBER) after previously serving as Acting Director.
Mikhail brings more than two decades of leadership experience across the pharmaceutical and biotechnology sectors and the FDA. Since joining the agency, he has worked on initiatives focused on clinical development, U.S. competitiveness, and domestic biopharmaceutical manufacturing.
As CBER Director, Mikhail will lead the FDA center responsible for regulating biological products, including cellular and gene therapies, vaccines, blood, and blood products. His responsibilities will also include efforts to modernize regulatory frameworks for therapeutic development, including in rare diseases.
Bret Koplow: Director of CTP
Bret Koplow, Ph.D., J.D., has been selected as Director of the Center for Tobacco Products (CTP) after serving as its Acting Director.
Koplow has worked at the FDA since 2011 and has held several senior legal, policy, and leadership roles. Before becoming Acting Director of CTP, he served as Senior Counselor to the FDA Commissioner, focusing primarily on regulatory, policy, and operational matters involving tobacco products. His FDA experience also includes positions in the Office of the Chief Counsel and Office of Legislation.
As CTP Director, Koplow will oversee the FDA center responsible for the regulation of tobacco products and related public health and regulatory activities.
New Leadership Across Key FDA Centers
The announcement places permanent leaders at CDER, CBER, and CTP, while also establishing a new senior FDA position focused specifically on technology and artificial intelligence.
For oncology and drug development, the appointments of Davis and Mikhail are particularly relevant, as CDER and CBER oversee the regulatory review of drugs and biologic products, including many cancer therapies, cellular therapies, and gene therapies.
HHS said the leadership selections are intended to support the FDA’s broader public health priorities while advancing innovation and regulatory modernization across the agency.
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