Significant regulatory shifts are underway at the FDA. Vinay Prasad was swiftly reinstated as director of CBER following political controversies, reflecting agency leadership volatility. Meanwhile, President Trump issued an executive order centralizing grant review powers with political appointees, potentially altering NIH funding and research oversight amidst backlash from scientific communities. Further, the FDA announced crackdowns on international shipment of biological materials for gene therapy, citing data security concerns. These developments mark a period of uncertainty and realignment impacting funding, policy, and regulatory compliance in biotechnology.