Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, will leave the agency at the end of April after a turbulent tenure marked by high‑profile rejections and reversals in vaccines, gene therapy, and rare‑disease reviews. The departure was confirmed by multiple outlets and by FDA leadership communications to staff. Prasad’s time at the agency included contentious decisions that prompted pushback from industry, patient groups and some political allies, as well as a prior brief removal and reinstatement. His exit leaves the top vaccines and biologics regulatory role vacant and raises questions about near‑term policy continuity for cell, gene and vaccine reviews. Agency officials have not named a successor; industry stakeholders note the timing comes amid heightened scrutiny of rare‑disease approvals and shifting regulatory expectations on trial design and evidentiary standards.