How the Critical Path Initiative Addresses CDER’s Regulatory Science Needs: Some Illustrative Examples

Abstract

Since 2008, the Critical Path Initiative has supported FDA's program of intramural research projects in regulatory science, with the goal of improving translation of advances in emerging sciences to the development of safe and effective medical products. Since 2011, the research of FDA's Center for Drug Evaluation and Research (CDER), including the work supported by the Critical Path Initiative, has been guided by the regulatory science needs identified in the CDER science and research needs report. In this review, the authors highlight a few of CDER'S Critical Path Initiative research projects, each addressing a different regulatory science need, to illustrate the diversity of regulatory science at CDER. They also describe elements common to these research projects, including broad collaboration with external partners, an increasing dependence on large data sets and computational models, and requirements for resources or perspectives specific to FDA.

Multifaceted Paths Toward Advancing Regulatory Science

“…In this issue of TIRS , we have an article by Drs M. Geanacopoulos and R. Barratt from the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER) at FDA. 1 They examine the role of the Critical Path Initiative in supporting regulatory science. They provide insight into 5 diverse projects that FDA undertook to address important scientific questions requiring data to support regulatory decision making, and they discuss the processes of defining the need for data-driven approaches and how such activities can be used in the regulatory milieu.…”