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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 E - Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses |
| § 312.80 - Purpose. |
| § 312.81 - Scope. |
| § 312.82 - Early consultation. |
| § 312.83 - Treatment protocols. |
| § 312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses. |
| § 312.85 - Phase 4 studies. |
| § 312.86 - Focused FDA regulatory research. |
| § 312.87 - Active monitoring of conduct and evaluation of clinical trials. |
| § 312.88 - Safeguards for patient safety. |