Expedited programs such as accelerated approval has been a critical tool to get promising new treatments to patients more quickly and have been the subject matter of an EU legislative proposal. However, such programs are increasingly a source of controversy, with new pressures emerging with respect to the trade-offs associated with residual uncertainties in approvals based on certain biomarkers or clinical endpoints, the costs of such products, the speed of confirmation of effectiveness via post-market clinical trials, and the use of real-world evidence to support such confirmation. This panel will take a comparative look at such expedited programs and examine these evolving regulatory and legal issues.