FDA leadership shifted again this week as Richard Pazdur filed retirement paperwork after a brief tenure and Tracy Beth Høeg, a Makary deputy and vaccine-safety investigator, was named acting director of the agency’s Center for Drug Evaluation and Research (CDER). The rapid personnel changes mark the fifth leader to run CDER this year and come amid broader turmoil at the agency. Industry officials flagged the churn as a governance and continuity risk for drug reviews and policy execution. The departures and appointment were reported in internal memos and industry coverage, and they coincide with a flurry of regulatory guidance proposals and high-stakes approval decisions across biologics and gene therapies. Companies with late-stage programs should expect increased scrutiny on review timelines and potential shifts in evidentiary expectations while the new acting director assumes oversight. Sponsors with upcoming filings are likely to seek early interactions to clarify data requirements and understand any near-term shifts in CDER priorities.