Vinay Prasad has been reinstated as the director of the FDA's Center for Biologics Evaluation and Research (CBER) just weeks after his abrupt ouster, following internal controversy and political backlash. His return, confirmed by the Department of Health and Human Services, signals a reversal in FDA leadership amidst tensions surrounding gene therapy product regulation and broader biopharma policy shifts. Prasad's leadership at CBER is critical as the FDA continues to navigate complex issues in vaccines, gene therapy, and biotech innovation. This development may impact regulatory consistency and industry confidence in the near term.