FDA, Center for Drug Evaluation and Research (CDER)

The Division of Rare Diseases and Medical Genetics (DRDMG) serves as a hub for rare disease drug development across the Office of New Drugs by coordinating rare disease education, policy, research and stakeholder engagement. DRDMG also regulates Investigational New Drug Applications (INDs), New Drug Applications (NDAs), and Biologics License Applications (BLAs) for drugs and biologics intended for the prevention and treatment of rare inborn errors of metabolism.

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