The role of academic medical centers in advancing regulatory science.

The US Food and Drug Administration (FDA) has oversight of an increasingly complex array of therapeutic and scientific advances, as well as an expanded mission that now includes enabling innovation. This complex mission necessitates access to and understanding of relevant scientific expertise in what is commonly called “regulatory science.” Academic medical centers have much of this relevant expertise, and there is an increasing need and opportunity for the FDA to engage with them to shape the regulatory science agenda.