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# FDA Accelerating Rare Disease Cures Program
- URL: https://www.fdaweb.com/fda-accelerating-rare-disease-cures-program/
- Published: 2022-05-10T12:00:00.000Z
- Updated: 2026-09-14T17:44:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151781

CDER says it has launched its new Accelerating Rare disease Cures (ARC) program to speed and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. An online [announcement](https://www.fda.gov/drugs/drug-safety-and-availability/cder-launches-new-accelerating-rare-disease-cures-arc-program?ref=fdaweb.com) says developing drugs for some 7,000 rare diseases and conditions can be complex due to: 

- the challenges in using well-established trial designs;
- the complexity of endpoint selection if there is a limited understanding of the disease’s natural history; and
- the difficulty in performing and interpreting rare disease clinical trials with small patient populations.

In its first year, CDER says, the ARC will focus on strengthening internal and external partnerships and will engage with external experts to help identify solutions for the challenges in rare disease drug development.