Reuters reported that FDA CDER chief Tracy Beth Høeg is expected to depart the agency following Commissioner Marty Makary’s resignation. Høeg previously became acting CDER director after Richard Pazdur’s exit last December. The reporting describes the leadership transition as likely part of a broader staffing shakeup at FDA, with internal uncertainty cited as an immediate risk for day-to-day review work. A spokesperson for the US Department of Health and Human Services said HHS and FDA do not comment on personnel matters. Regulatory upheaval can affect timelines for submissions and internal policy alignment, particularly across oncology and high-urgency drug development programs managed through CDER.