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BioPharma Dive·Sep 9·1 min read
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FDA appoints permanent heads of CDER and CBER, adding AI deputy role

Sep 9, 2026·read at BioPharma Dive ↗RegulatoryPositive

The Trump administration announced permanent appointments to two key FDA centers after a period of turnover.

Michael Davis, who had been acting director of the Center for Drug Evaluation and Research, is now the permanent director, and Karim Mikhail, previously interim head of the Center for Biologics Evaluation and Research, also assumes the role permanently.

The agency created a new deputy commissioner position for technology and artificial intelligence, filled by Jared Seehafer, and named Bret Koplow as director of the Center for Tobacco Products.

Analysts say the moves should bring continuity and ease concerns about further instability that had worried drugmakers and investors.

source

This writeup was produced by pharmadog from original reporting by BioPharma Dive.

Original headline: “FDA gains ‘continuity’ as Mikhail, Davis named permanent CBER, CDER leaders”

read at BioPharma Dive ↗
638 words · retrieved Sep 9
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ELI LILLY COLEADINGLILLYUltragenyx Pharmaceutical Inc.
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