Virginia Center for Translational and Regulatory Sciences, University of Virginia School of Medicine, Charlottesville, Virginia, USA.
Clin Pharmacol Ther. 2014 May;95(5):471-3. doi: 10.1038/clpt.2014.33.
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.
美国食品和药物管理局（FDA）负责监管日益复杂的治疗和科学进步，以及扩大的任务，现在包括促进创新。这项复杂的任务需要获得并理解通常被称为“监管科学”的相关科学专业知识。学术医疗中心拥有大量相关专业知识，FDA 越来越需要并有机遇与它们合作，制定监管科学议程。
