Tidmarsh signals higher bar for accelerated approvals but faster trial starts
CDER director says FDA is re-evaluating cancer endpoints and moving to speed clinical trial regulation, including IND process
With the DOGE wrecking ball retired and the dust beginning to clear, FDA’s new direction is coming into view. The picture is complex, but several clear themes have emerged: a morale-sapping divide between leadership and staff; growing politicization that is making regulatory decisions more unpredictable; and an eagerness to align FDA’s work with the Trump administration’s Make America Healthy Again and America First agendas.
Beneath these overarching trends, the agency is being pulled in conflicting directions. One force is pushing toward tougher approval standards, especially for accelerated approvals in cancer and rare diseases, while another is driving to boost U.S. competitiveness by streamlining clinical trial regulation and addressing demands from patients by lowering barriers for therapies targeting ultrarare conditions...