Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D)

https://www.fda.gov/about-fda/accelerating-rare-disease-cures-arc-program/learning-and-education-advance-and-empower-rare-disease-drug-developers-leader-3d?utm_medium=email&utm_source=govdelivery Now Available: Two LEADER 3D Videos on Understanding the Importance of Endpoints and Considerations for Collecting and Using Natural History Data The CDER ARC Program’s Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative published two new videos titled “Understanding the Importance of Endpoints in Rare Disease Drug Development” and “Considerations for Collecting and Using Natural History Study Data that are Fit for Use in the Regulatory Setting” to the educational video series. The videos provide an overview of important considerations for selecting endpoints when designing clinical trials, and concepts to consider when determining how to leverage natural history study data in rare disease drug development programs.