Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will depart the agency at the end of April, officials confirmed. Prasad’s tenure was marked by a string of high‑profile rejections of rare‑disease and gene‑therapy applications and public clashes with patient advocates and industry stakeholders. Reports note his policy shifts on vaccine guidance and increased scrutiny of cell and gene therapy approvals under his watch. The exit leaves CBER leadership in flux ahead of several regulatorily sensitive reviews and underscores ongoing tensions between the agency’s reviewers and industry on evidentiary standards for novel biologics.