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Code of Federal Regulations (Last Updated: April 5, 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 |
| Subpart A - General Provisions |
| § 312.1 - Scope. |
| § 312.2 - Applicability. |
| § 312.3 - Definitions and interpretations. |
| § 312.6 - Labeling of an investigational new drug. |
| § 312.7 - Promotion of investigational drugs. |
| § 312.8 - Charging for investigational drugs under an IND. |
| § 312.10 - Waivers. |
| 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. |
| Subpart C - Administrative Actions |
| § 312.40 - General requirements for use of an investigational new drug in a clinical investigation. |
| § 312.41 - Comment and advice on an IND. |
| § 312.42 - Clinical holds and requests for modification. |
| § 312.44 - Termination. |
| § 312.45 - Inactive status. |
| § 312.47 - Meetings. |
| § 312.48 - Dispute resolution. |
| Subpart D - Responsibilities of Sponsors and Investigators |
| § 312.50 - General responsibilities of sponsors. |
| § 312.52 - Transfer of obligations to a contract research organization. |
| § 312.53 - Selecting investigators and monitors. |
| § 312.54 - Emergency research under § 50.24 of this chapter. |
| § 312.55 - Informing investigators. |
| § 312.56 - Review of ongoing investigations. |
| § 312.57 - Recordkeeping and record retention. |
| § 312.58 - Inspection of sponsor's records and reports. |
| § 312.59 - Disposition of unused supply of investigational drug. |
| § 312.60 - General responsibilities of investigators. |
| § 312.61 - Control of the investigational drug. |
| § 312.62 - Investigator recordkeeping and record retention. |
| § 312.64 - Investigator reports. |
| § 312.66 - Assurance of IRB review. |
| § 312.68 - Inspection of investigator's records and reports. |
| § 312.69 - Handling of controlled substances. |
| § 312.70 - Disqualification of a clinical investigator. |
| 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. |
| Subpart F - Miscellaneous |
| § 312.110 - Import and export requirements. |
| § 312.120 - Foreign clinical studies not conducted under an IND. |
| § 312.130 - Availability for public disclosure of data and information in an IND. |
| § 312.140 - Address for correspondence. |
| § 312.145 - Guidance documents. |
| Subpart G - Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests |
| § 312.160 - Drugs for investigational use in laboratory research animals or in vitro tests. |
| Subpart H - XXX |
| 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. |