The FDA appointed Tracey Beth Høeg as acting director of the Center for Drug Evaluation and Research (CDER), continuing rapid turnover at the agency’s senior ranks. Høeg, who served as a special assistant to the commissioner and worked on vaccine-safety issues, takes the role amid a string of leadership changes that industry and former agency officials say could prompt staff departures and operational disruption. BioCentury reporting flagged that the appointment is expected to result in further staff exits and ease constraints on top FDA leaders, citing internal reactions and leadership shifts. The move comes as the agency retools review processes and policy priorities under new senior management. Companies with drugs in late-stage development and regulatory review will be watching how the leadership change affects review timelines and regulatory expectations. Regulatory stakeholders told reporters they expect immediate personnel churn and a period of internal realignment at CDER. The appointment adds another variable for sponsors planning filings or interacting with the agency early next year.
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