As the clinical research landscape progresses, so do the expectations of regulators. The U.S. Food and Drug Administration (FDA) has made it clear: real-world data (RWD) has the potential to enhance the efficiency and relevance [...]

Access to unlicensed or investigational medicines outside of clinical trials prior to marketing authorization plays a critical role in addressing urgent, unmet clinical needs in patient populations. Within the European Union (EU), such access is [...]