Reuters reported that Tracy Beth Høeg, MD, PhD—acting director of the FDA’s Center for Drug Evaluation and Research (CDER) after the resignation of Richard Pazdur—was expected to leave the agency following Commissioner Marty Makary’s exit. The report cites internal planning and frames the likely departure as part of broader leadership churn across US health agencies. It also ties the timing to a White House effort described as aiming to reshape FDA staffing and reduce uncertainty for policy risk, including around politically sensitive areas such as vaccines. Høeg’s expected departure would add to industry concern that ongoing clinical and regulatory work could face disruption as senior leadership turns over. The Reuters report also notes that the decision is not finalized and that HHS and FDA do not comment on personnel matters. For biotech leaders, changes at CDER leadership can quickly affect the tone of review priorities, resourcing of review units, and the day-to-day predictability of interactions with regulators.
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