Improving the Science of Development and Review

Recent advances in the fields of science and technology have the potential to transform our understanding of disease and the practice of medicine. These advances include breakthroughs in our understanding of human biology and disease pathology, as well as the rapid development of new information systems and digital technologies that can collect and analyze massive amounts of data. Translating these advances into ground-breaking new medical treatments will require a more modernized, efficient, and science-based regulatory infrastructure.

The US Food and Drug Administration (FDA) has a key role to play in shaping this infrastructure as it evolves. About 25 cents of every dollar spent by American consumers each year goes towards products that are regulated by the agency. In order to ensure the quality, safety, and effectiveness of these products—both those under development and those currently on the market—the FDA needs rigorous tools, standards, and approaches to assessing them.

The Duke Margolis Center works closely with the agency to convene expert workshops and public conferences aimed at informing FDA’s approach to reviewing and regulating medical products. These convening activities generally fall within four general categories of focus:

Supporting the Development and Use of New Drug Development Tools
Standardizing and Improving Post-Market Safety Regulation
Exploring Innovative Statistical Methods and Trial Designs
Enhancing Regulatory Review Processes for Medical Products