IQVIA艾昆纬：2024年监管文件中的RWD与RWE最佳实践：成功监管互动的关键要点白皮书（英文版）

The contribution of real-world evidence (RWE) to regulatory submissions as supportive or substantial evidence has increased in the pre-marketing authorisation space over the last decade. An extensive series of guidance documents have been put forth by the United States (US) Food and Administration (FDA) on the use of real-world data (RWD) and RWE in regulatory submissions, with several guidance themes emerging. Sponsors are required to navigate this diverse body of information when planning and