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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 B - Written Recommendations for Investigations of Orphan Drugs |
| § 316.10 - Content and format of a request for written recommendations. |
| § 316.12 - Providing written recommendations. |
| § 316.14 - Refusal to provide written recommendations. |