CDER debuts new ARC program

The US Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) has announced the launch of the new Accelerating Rare disease Cures (ARC) Program.

The vision of CDER’s ARC Program is speeding and increasing the development of effective and safe treatment options addressing the unmet needs of patients with rare diseases. This is a CDER-wide effort with leadership represented from several offices throughout the Center.

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