Snapshot

The Accelerating Rare disease Cures (ARC) Program pathway has been developed by the US Food and Drug Administration of United States.

This pathway can be used where FDA’s Center for Drug Evaluation and Research (CDER) 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 pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

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