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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter D - Drugs for Human Use |
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Part 316 - Orphan Drugs |
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Subpart D - Orphan-drug Exclusive Approval |
| § 316.31 - Scope of orphan-drug exclusive approval. |
| § 316.34 - FDA recognition of exclusive approval. |
| § 316.36 - Insufficient quantities of orphan drugs. |