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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 312 - Investigational New Drug Application |
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Subpart B - Investigational New Drug Application (IND) |
| § 312.20 - Requirement for an IND. |
| § 312.21 - Phases of an investigation. |
| § 312.22 - General principles of the IND submission. |
| § 312.23 - IND content and format. |
| § 312.30 - Protocol amendments. |
| § 312.31 - Information amendments. |
| § 312.32 - IND safety reporting. |
| § 312.33 - Annual reports. |
| § 312.34 - Treatment use of an investigational new drug. |
| § 312.35 - Submissions for treatment use. |
| § 312.36 - Emergency use of an investigational new drug (IND). |
| § 312.38 - Withdrawal of an IND. |