The Center for Drug Evaluation and Research's ARC Program Releases 2026 Annual Report
In brief
FDA CDER's Accelerating Rare disease Cures (ARC) Program has released its 2026 annual report, summarizing the year's progress under its three goals: scientific and regulatory innovations, engagement and education, and operations. The report presents ARC's 2025–2030 strategic plan, along with the LEADER 3D case study and educational resource expansion, advances in statistical methodologies, translational science research, and international regulatory collaboration. The report states that half of CDER's novel drug approvals in 2025 represented rare disease treatments.
Why it matters
The annual report consolidates regulatory and scientific tool progress in rare disease drug development and lays out a 2025–2030 strategic roadmap for stakeholders.
