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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 I - Expanded Access to Investigational Drugs for Treatment Use |
| § 312.300 - General. |
| § 312.305 - Requirements for all expanded access uses. |
| § 312.310 - Individual patients, including for emergency use. |
| § 312.315 - Intermediate-size patient populations. |
| § 312.320 - Treatment IND or treatment protocol. |