After FDA Commissioner Marty Makary resigned, Reuters reported that Tracy Beth Høeg, MD, PhD, who has been leading CDER, is expected to leave the agency as well, citing internal plans from sources. The report frames the leadership changes as part of a broader shift and notes that the decision may not be finalized. The personnel shakeup comes amid uncertainty for agency execution, particularly around ongoing review workflows and day-to-day decision-making. Affected leadership includes CDER’s acting transition following the departure of Richard Pazdur in December. While HHS and FDA declined to comment on personnel matters, industry experts quoted by the report characterized the exits as likely to create operational uncertainty and may obscure longer-term regulatory priorities. The reported shakeup also signals potential turbulence in how politically sensitive areas of drug policy are managed, even as the agency continues to process applications and post-market actions.