The U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) saw another leadership shift as longtime oncology regulator Peter (Pat) Pazdur resigned and Tracy Beth Høeg was tapped as acting director. The moves come after a year of unusually rapid turnover at the agency and public debate over vaccine policy and approval standards. Observers linked Høeg’s appointment to shifting vaccine strategy at the FDA given her epidemiology background and prior co-authorship of controversial vaccine-safety analyses. Industry and advocacy groups signaled concern about regulatory continuity; analysts warned the changes could affect review timelines and industry expectations for vaccine and drug approvals. FDA insiders and stakeholders are watching for near-term internal departures and policy recalibrations, particularly around vaccine assessment and oncology review processes. Companies with active regulatory interactions should prepare for evolving points of contact and potentially modified evidence expectations, analysts say.