On May 2022, the US-FDA’s Center for Drug Evaluation and Research (CDER) announced the launch of the new Accelerating Rare disease Cures (ARC) Program. The CDER ARC Program intention is to speed up and increase the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. 


FDA defines rare disease as any disease that affects less than 200,000 people in the U.S. Drug development for the approximately 7,000 rare diseases and conditions can be complex for many reasons:

  • There can be challenges with using well-established trial designs.
  • Endpoint selection can be complex if there is a limited understanding of the natural history of the disease.
  • Small patient populations can make it difficult to perform and interpret rare disease clinical trials.

What are the objectives and advantages of the Program for Treating Rare Diseases?

Through scientific and regulatory innovation and engagement, CDER’s ARC Program will help support the development and approval of safe and effective treatment options for the more than 30 million people living with a rare disease in the U.S.

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

CDER's ARC Program

 CDER’s Accelerating Rare disease Cures (ARC) Program provides strategic overview and coordination of CDER’s rare disease activities. CDER’s ARC Program is governed by leadership from across CDER’s Office of the Center Director, Office of New Drugs, and the Office of Translational Sciences. The program is managed by CDER’s Rare Diseases Team.

What is CDER's priority?

To continue to make Rare Diseases a priority with drug approvals and programming to accelerate therapeutic development.

The FDA’s Center for Drug Evaluation and Research (CDER) has teams and programs that are dedicated to overcoming these hurdles and facilitating the development of therapies for the more than 30 million people living with a rare disease in the U.S. The combination of government incentives and scientific advancements has fueled extraordinary development of drugs for rare diseases.

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