The U.S. Food and Drug Administration (FDA) faces unprecedented challenges in providing effective regulatory oversight due to the increasing complexity of medical products, the scale and globalization of industry operations, and the growing demand for personalized medicines and therapies. These challenges are compounded by the expanding gap between the FDA’s increased regulatory oversight responsibilities enacted through legislative mandates without commensurate changes in resources and funding.
Booz Allen bridges this gap through the implementation of novel methodologies and robust tools that more effectively assess the safety, efficacy, quality, and availability of FDA-regulated products. Across more than 15 years supporting the organization’s user fee programs, Booz Allen has empowered the FDA to make timely regulatory decisions that enable biomedical innovation while promoting and protecting public health.
Regulatory science is the development of innovative science-based decision-making processes, tools, and standards to fulfill the responsibilities of a public health agency. Read about our approach, our people, and our successes in solving complex problems that advance medical product innovation and promote public health in the Regulatory Science Playbook.