ODLevel 1

Orphan Drug Types

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OD.01Rare Disease Drug

OD.02Ultra-Rare Disease Drug

OD.03Orphan Biologic

OD.04Orphan Gene Therapy

OD.05Orphan Cell Therapy

OD.06Orphan Enzyme Replacement

OD.07Orphan Small Molecule

OD.08Orphan Antibody

OD.09Pediatric Orphan Drug

OD.10Orphan Drug Designation

OD.11Breakthrough Therapy Designation

OD.12Accelerated Approval

OD.13Priority Review Voucher

Cross-system equivalences2

NAICS 2022

3254Pharmaceutical and Medicine Manufacturingbroad 5417Scientific Research and Development Servicesbroad

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