The director of the FDA Office that oversees orphan drug designations was removed from the role and reassigned, an administrative official confirmed. Sandra Retzky’s reassignment affects the office responsible for determining orphan status, incentives and associated interactions with sponsors developing therapies for rare diseases. Industry and rare‑disease advocates will watch for any operational changes that could affect designation timelines or policy interpretation. The agency did not provide detailed reasons publicly; sponsors should monitor communications from FDA for potential process updates and plan engagement strategies accordingly.