Accelerating Rare disease Cures (ARC) Program

https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/accelerating-rare-disease-cures-arc-program?utm_medium=email&utm_source=govdelivery The U.S. Food and Drug Administration (FDA) has released the 2025 Accelerating Rare disease Cures (ARC) Program Annual Report. Since its launch in 2022, the Center for Drug Evaluation and Research (CDER) ARC Program continues to be a key resource for the rare disease community and a driver of innovative approaches for rare disease drug development. The ARC Program is dedicated to driving scientific and regulatory innovation and engagement while closing the gap between the challenges of developing drugs for rare diseases and the urgent need for treatment options for patients. Having built a strong foundation, the ARC Program is enthusiastic about the upcoming year as it continues to strengthen partnerships and empower innovation for rare disease drug development. CDER and the ARC Program maintain an unwavering commitment to improving outcomes and options for the rare disease community. To learn more about the ARC Program, its accomplishments in 2025, and the future outlook of the program, please visit Accelerating Rare disease Cures (ARC) Program Annual Report: Resilience in Rare Disease Drug Development through Innovation and Partnerships.