In May 2022, FDA CDER launched the Accelerating Rare disease Cures (ARC) Program to bridge the gap
between the complexities of rare disease drug development and the pressing needs of patients with
rare diseases to have treatment options. The ARC Program has emerged as a conduit for empowering
rare disease stakeholders (including patients, patient advocates, drug developers, researchers, and
federal partners) to harness their collective experiences and expertise to drive progress. One notable
initiative launched is the Learning and Education to Advance and Empower Rare Disease Drug
Developers (LEADER 3D) project by CDER’s Rare Diseases Team (RDT). In a year until May 2023, FDA
approved 22 rare disease drugs. To know more of the Arc program and view the FDA annual update,
please click on the following link:
https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cders-arc-program

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