The U.S. Department of Health and Human Services has appointed permanent leaders for several key FDA positions, filling roles that had been vacant for months and bringing greater stability to the agency.
Michael Davis will lead the Center for Drug Evaluation and Research (CDER), which oversees all prescription, generic and over-the-counter medicines. Karim Mikhail will lead the Center for Biologics Evaluation and Research (CBER), the division responsible for vaccines, blood products, gene therapies and other biological products.
The FDA has also created a new senior technology and AI position, with Jared Seehafer appointed as its first deputy commissioner for technology and artificial intelligence. The new role reflects the agency's growing focus on integrating artificial intelligence into its regulatory processes.
A Return to Stability
The appointments come after a period of significant instability at the FDA. The agency has experienced major staff losses and leadership changes in recent years, with several key positions either vacant or filled on an acting basis.
Michael Davis brings extensive experience in drug regulation to his new role. Karim Mikhail joins from the biotech industry, where he held leadership positions at several vaccine and biologics companies.
The creation of the deputy commissioner for technology and AI position signals the FDA's recognition that artificial intelligence is becoming increasingly central to drug development and regulatory review. The agency has already been using AI to accelerate the review of drug applications and to analyse vast datasets from clinical trials.
Industry Reaction
The appointments have been welcomed by the pharmaceutical and biotech industries, which had expressed concerns about the leadership vacuum at the FDA.
Industry groups have noted that permanent leadership provides clarity and direction for the agency's regulatory decisions. The appointments are expected to help restore confidence in the FDA's ability to review new therapies efficiently and rigorously.