PS35: One Drug, Two Agencies: FDA and EMA. Similarities, Differences, Learning from One Another

The Food and Drug Administration (FDA) and European Medicines Agency (EMA) are the world's leading and most influential regulatory authorities, controlling access to key markets and over 800 million patients. While the fundamental mission of ensuring drug safety and efficacy is the same, there are key differences in how both FDA and EMA guide drug development or review marketing applications. In this session, we will discuss a comparative analysis of the framework and processes of the FDA and EMA and the role of the statistician in this process, including suggestions on what we may learn from one another. We will also include an industry perspective on satisfying two regulatory requirements with the same study, including in a situation where there is conflicting advice.