In a move to solidify leadership positions at the US Food and Drug Administration (FDA), the US Department of Health and Human Services (HHS) has named the Acting Heads of the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), and the Center for Tobacco Products (CTP) to permanent roles and also named the agency’s First Deputy Commissioner for Technology and Artificial Intelligence. The moves come as the Administration looks to fill the top post of FDA with Dr. Heidi Overton, M.D., currently Deputy Director of the White House Domestic Policy Council, nominated last month (August 2026) to serve as the next FDA Commissioner, subject to confirmation from the US Senate.  

Making heads of CDER, CBER, CTP permanent 
Michael Davis, M.D., Ph.D., has been selected as Director of CDER, the center within FDA that regulates prescription drugs, both innovator drugs and generic drugs and biosimilars, and over-the-counter drugs. Davis, formerly Deputy Center Director of CDER, became the Acting Center Director for CDER in May 2026 and has now been named to lead CDER on a permanent basis. HHS says he will direct CDER’s reform and innovation agenda with a focus on three critical areas: increasing patient access to safe and affordable critical medicines, advancing the science of drug development and evaluation, and strengthening the domestic and global drug supply chain 

He becomes the sixth official to lead CDER since the current Administration took the helm in January 2025. He succeeded Beth Høeg, M.D., Ph.D., was who named Acting Director of CDER in December 2025 and who left that post in May 2026. She joined FDA in March 2025, first as a Special Assistant and then as Senior Advisor for Clinical Sciences to then FDA Commissioner, Dr. Marty Makary, M.D. She had taken over from Richard Prazur, who was named CDER Director in November 2025 and served as CDER Director for a single month. He had taken over from Dr. George Tidmarsh, M.D., Ph.D., who was CDER Director for only a few months having been appointed in July 2025 and leaving the post in November 2025. He had taken over from Jacqueline Corrigan-Curay, M.D., who served as CDER’s Acting Director from January to July 2025 after its former head, Patrizia Cavazzoni, M.D., stepped down earlier in January 2025. Cavazzoni served as Director of CDER from April 2021 to January 2025. 

Karim Mikhail, B.Pharm, MSc, has been selected as Director of CBER, which regulates blood products, vaccines, allergenics, tissues, and cellular and gene therapies. Mikhail became Acting Director of CBER in May (May 2026). He joined FDA in 2025 as a Senior Advisor in the Office of the Commissioner, where he led US competitiveness reforms, spanning multiple disciplines from accelerating early clinical development to onshoring of bio/pharmaceutical manufacturing. He succeeded Vinay Prasad, M.D., formerly CBER’s Director, who stepped down for the second time having previously temporarily leaving the post in July 2025. 

In addition, Bret Koplow, Ph.D., J.D., currently Acting Director of CTP, which regulates the manufacturing, marketing, and distribution of tobacco products, has been selected to lead the center on permanent basis. 

FDA’s First Deputy Commissioner for Technology & AI 
In a newly created position, Jared Seehafer, M.S. has been selected to serve as FDA’s first Deputy Commissioner for Technology and Artificial Intelligence. In this role, he will serve as the agency’s senior leader for technology, software, and AI and will provide leadership in establishing FDA-wide strategy and priorities in these areas. 

Seehafer brings two decades of technical and leadership experience at the intersection of software, AI, and FDA-regulated medical technology. HHS says the newly created position underscores the Administration’s commitment to accelerating reliable AI innovation, modernizing federal technology, and ensuring an effective regulatory framework for emerging technologies. 

Source: US Health and Human Services Department