FDA commissioner Dr. Margaret Hamburg launched a new initiative to innovate regulatory science so that it can keep pace with the evolution of biomedical research. New pilot and feasibility studies are proposed to investigate early drug safety and efficacy. In addition, use of genetic data and biomarkers may further elucidate disease targets and support efforts to optimize clinical trial design. A key part of the plan is to set up centers of excellence in regulatory science, which would most likely be housed in academic centers, and would bring academia, FDA, and industry together in collaboration. A new office, dedicated to regulatory science, will lead strategic development and co-ordination within FDA. Initial efforts will focus on recruiting key personnel and building senior leadership.