Abstract 

In 2025, the US Food and Drug Administration (FDA) has undergone significant transformation amid widespread governmental change. Leadership turnover, shifting priorities, altered processes and reduced staffing have all reshaped the agency’s operations. Nevertheless, the FDA continues to uphold its essential role in safeguarding public health and ensuring regulatory oversight. Despite disruptions, it has launched several new pilot programmes and initiatives designed to enhance efficiency, encourage innovation and modernise its approach to regulation. This article reviews the most notable new pilots and existing programmes.