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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  5. Accelerating Rare disease Cures (ARC) Program
  6. Rare Diseases Team
  1. Accelerating Rare disease Cures (ARC) Program

Rare Diseases Team

Mission Statement

To facilitate, support and accelerate the development of drug and biologic products for the benefit of patients with rare disorders.

Overview

  • Coordinate the development of CDER policy, procedures and training for the review of treatments for rare diseases.
  • Assist in outside development and maintenance of good science as the basis for the development of treatments for rare diseases.
  • Work collaboratively with external and internal rare disease stakeholders to promote the development of treatments for rare disorders.
  • Maintain collaborative relationships with CDER's review divisions to promote consistency and innovation in the review of treatments for rare disorders.
  • Work collaboratively with international regulatory agencies to discuss and exchange scientific and regulatory information related to rare diseases.

CDER’s Rare Diseases Team PDUFA VI and VII Commitments

Selected Conferences

Rare Disease Resources

Please check back for more anticipated updates.

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