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

Accelerating Rare disease Cures (ARC) Program inaugurated the Learning and Education to ADvance and Empower Rare Disease Drug Developers (LEADER 3D) initiative to better understand and address the unique challenges in bringing rare disease products regulated by FDA CDER to the market. emphasizes a deeper understanding of regulatory policies, and engages with rare disease community to achieve this goal. LEADER 3D develops educational materials to enhance understanding of regulatory drug development for rare diseases. Materials generated include videos and case studies for both external stakeholders and FDA review staff involved in the development of rare disease drugs. The materials have been viewed by thousands of individuals and have garnered positive press reports on their rigor and usefulness.If the contract were not renewed, these positive contributions to the design, conduct and review of rare disease drug development programs will be impeded drug development for rare diseases, contributing to the ongoing unmet medical need.