HHS on 8 September 2026 made permanent three FDA center directors who had been serving in acting roles, and created a new position with no precedent at the agency: Deputy Commissioner for Technology and Artificial Intelligence. The four appointments, announced together, give sponsors settled leadership atop the drug, biologics, and tobacco centers after months of acting management — and put a former regulatory-technology executive in a newly created seat with authority that reaches across every center's software and AI work.
Three centers get settled leadership
Michael Davis, a psychiatrist with more than eight years at FDA, had served as acting director of CDER since May 2026; he is now permanent. HHS said his priorities as CDER Director are increasing patient access to safe and affordable medicines, advancing the science of drug development and evaluation, and strengthening the domestic and global drug supply chain.
Karim Mikhail, a former Merck official, took over as acting CBER Director in May 2026 after Vinay Prasad left the position for a second time that April. He is now permanent. CBER regulates biological products, including cell and gene therapies, vaccines, and blood and blood products — a portfolio that has seen unusually frequent leadership turnover this year.
Bret Koplow, who holds both a Ph.D. and a J.D., had been serving as acting director of the Center for Tobacco Products. He is now permanent. HHS described CTP's priorities under Koplow as promoting innovation and access to less-harmful alternatives for adult smokers while taking action to protect youth and minors from tobacco and nicotine products.
A new role built around software and AI
The fourth appointment has no direct predecessor. Jared Seehafer is FDA's first Deputy Commissioner for Technology and Artificial Intelligence, a role HHS describes as setting FDA-wide strategy and priorities for technology, software, and AI — not a single center's policy, but one that cuts across CDER, CBER, and CDRH alike. Seehafer co-founded and led Enzyme, a company building regulatory and compliance software for life-sciences companies, before joining FDA in 2025 as a Senior Advisor in the Office of Policy, Legislation, and International Affairs, where he worked on cross-cutting device, software, and AI policy matters.
The position's scope matters as much as who holds it. CDRH has spent the past year developing its own thinking on AI-enabled devices, including an August discussion paper proposing a two-axis risk framework and competency-based review for generative AI-enabled medical devices. A deputy commissioner sitting above the centers, rather than inside one of them, suggests FDA wants a single point of coordination for how that thinking — and parallel efforts inside CDER and CBER on AI in drug development and manufacturing — fits together agency-wide.
What this means for sponsors
For regulatory affairs teams, the immediate effect is predictability: CDER and CBER have had acting directors for most of 2026, and permanent leadership typically signals more continuity in review-division priorities and less turnover risk mid-cycle for pending applications. The AI deputy commissioner appointment is a longer-lead signal — it does not itself change any guidance or review standard, but it identifies who inside FDA will now own the agency's cross-center approach to software and AI policy, which is where sponsors developing AI-enabled devices, digital health tools, or AI-assisted drug development pipelines should expect the next round of coordinated guidance to originate.
Frequently asked questions
Who was named to lead FDA's drug and biologics centers?
On 8 September 2026, HHS named Michael Davis permanent Director of CDER and Karim Mikhail permanent Director of CBER. Both had been serving in acting capacities since May 2026. Bret Koplow was named permanent Director of the Center for Tobacco Products, where he had also been acting director.
What is the new Deputy Commissioner for Technology and Artificial Intelligence?
It is a newly created, agency-wide executive role with no prior occupant. HHS named Jared Seehafer to fill it. The position sets FDA-wide strategy and priorities on technology, software, and AI, rather than sitting inside a single center such as CDRH.
Who is Jared Seehafer?
Seehafer is the co-founder and former CEO of Enzyme, a life-sciences regulatory and compliance technology company. He joined FDA in 2025 as a Senior Advisor in the Office of Policy, Legislation, and International Affairs, working on cross-cutting device, software, and AI policy. He holds a master's degree in medical device and diagnostic engineering from the University of Southern California and a bachelor's degree in molecular, cellular, and developmental biology from the University of Colorado Boulder.
Why does this matter for sponsors?
Permanent center directors give sponsors more predictability after months of acting leadership at CDER and CBER. The new AI deputy commissioner role signals that FDA intends to coordinate its technology and AI policy centrally, across CDER, CBER, and CDRH, rather than leaving it to individual centers to set their own approaches.
Sources & further reading
- U.S. Department of Health and Human Services, “HHS Announces Key Leadership Selections at FDA to Promote Innovation, Reform, and National Health Priorities,” 8 September 2026. hhs.gov
- RAPS, “FDA names permanent CDER, CBER directors, new deputy commissioner for AI,” 8 September 2026. raps.org
- FDA, staff biography page for Jared Seehafer, Deputy Commissioner for Technology and Artificial Intelligence. fda.gov
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