Acting CBER, CDER heads become permanent as FDA works to restore stability

News FDA Acting CBER, CDER heads become permanent as FDA works to restore stability September 9, 2026 | 2 min read | Tristan Manalac Twitter LinkedIn Facebook Email Print The decision to promote Michael Davis and Karim Mikhail from acting to permanent division heads comes as the FDA awaits the potential confirmation of Heidi Overton, President Donald Trump’s nominee for commissioner. The current acting leaders of the FDA’s drugs and biologics regulatory divisions will now serve in a permanent capacity, bringing what analysts say is “much-needed leadership continuity” to the agency.“The appointment of the current interim directors is likely to be seen as a sign of continuity and stability that should help ease concerns that the FDA will see major shifts in policy,” RBC Capital Markets told investors in a Wednesday afternoon note. These permanent positions come amid the looming yet-unscheduled confirmation hearing of Heidi Overton, President Donald Trump’s pick for FDA commissioner.“We do not expect another ‘larger-than-life’ commissioner looking to remake the Agency,” the RBC analysts noted, referring to previous agency chief Marty Makary, whose tenure was marked by several controversies.

Overton’s confirmation, if it comes to pass, “will lead to delegation of key duties to division directors”—including the new permanent division heads, according to the analysts.Moving forward, Karim Mikhail will take charge of the Center for Biologics Evaluation and Research, according to a Tuesday news release from the Department of Health and Human Services. Meanwhile, the Center for Drug Evaluation and Research will be led by Michael Davis. Both Mikhail and Davis have led their respective departments since mid-May, following the departures of Makary and division heads Tracy Beth Høeg and Vinay Prasad, who were similarly tied to controversial FDA actions.

Serving in an acting capacity, both Davis and Mikhail emphasized that their priority was to restore a sense of normalcy at the agency and engage with the remaining staff while working to stop further attrition and rebuild the workforce. By most accounts, the leaders were well liked, serving in what William Blair analysts called “caretaker mode” following a tumultuous year. FDA BIO 2026: FDA’s IND initiative is a step toward normalization after slipshod year Policymaking at FDA has been anything but business as usual under the Trump administration, but former regulators cite the agency’s new investigational new drug pilot program as a sign of normalcy.

June 25, 2026 · 3 min read · Jef Akst Read more Alongside Davis and Mikhail, Jared Seehafer will become Deputy Commissioner for Technology and Artificial Intelligence at the FDA, HHS said of the newly created role. Seehafer’s appointment follows reports last month that the agency had been considering two new deputy posts, including one focused on AI and another on drugs. The latter role has yet to be formally announced.Seehafer formally served as a senior adviser within the Office of the Commissioner.

He co-founded and had served as CEO of Enzyme, a company that helps drugmakers through the compliance and regulatory processes using technology.Finally, Brent Koplow will lead the Center for Tobacco Products. Koplow, who has already been serving as the center’s acting director, has been with the FDA since 2011, taking on several senior legal, policy and leadership roles. FDA Capricor, Replimune reviews signal FDA’s return to reliability but every application will stand alone Following a tumultuous stretch under ex-Commissioner Marty Makary, current FDA leadership is working to restore reliability, integrity and transparency to the agency—but experts say that doesn’t necessarily mean an easier regulatory road for drugmakers.

August 24, 2026 · 6 min read · Tristan Manalac Read more Twitter LinkedIn Facebook Email Print Regulatory Government People Tristan Manalac Tristan is BioSpace‘s senior staff writer. Based in Metro Manila, Tristan has more than eight years of experience writing about medicine, biotech and science. He can be reached at tristan.manalac@biospace.com, tristan@tristanmanalac.com or on LinkedIn.