|
Abstract:
|
Real-world data (RWD) have played an important role throughout drug development lifecycle, such as informing disease prevalence, patient characteristics, standard of care, natural history and unmet medical need for pipeline products, while providing evidence of post-marketing safety and effectiveness for marketed products. In recent years, especially since PDUFA VI, there has been a surge in the use of real-world evidence (RWE) in registrational setting. A few industry case examples of using RWD to support regulatory decision-making of a new indication or label expansion will be presented as the context to share our experience, and to discuss challenges, lessons learned, good practices and future opportunities.
|
