More FDA leaders are departing. Here’s what the turmoil may mean for agency policies and priorities

By Laura DiAngelo, MPH, Alexander Gaffney, MS, RAC and Ned Pagliarulo

A growing wave of leadership departures at the FDA is creating uncertainty around several high-profile agency initiatives launched under former Commissioner Martin Makary. The turnover affects multiple senior officials across drug, biologics and strategic leadership roles, leaving many programs without the leaders most closely associated with their development.

The shake-up raises questions about the future of initiatives tied to accelerated reviews, AI, inspections, clinical trial modernization and over-the-counter drug transitions, particularly as the agency awaits more permanent leadership.

This AgencyIQ analysis examines how the leadership changes could affect FDA policymaking, operational priorities and the direction of key regulatory initiatives.

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