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Section 312.1
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Applicability |
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Section 312.2
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Definitions and interpretations |
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Section 312.3
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Labeling of an investigational new drug |
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Section 312.6
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Promotion of investigational drugs |
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Section 312.7
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Charging for investigational drugs under an IND |
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Section 312.8
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Waivers |
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Section 312.10
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Requirement for an IND |
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Section 312.20
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Phases of an investigation |
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Section 312.21
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General principles of the IND submission |
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Section 312.22
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IND content and format |
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Section 312.23
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Protocol amendments |
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Section 312.30
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Information amendments |
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Section 312.31
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IND safety reporting |
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Section 312.32
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Annual reports |
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Section 312.33
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Withdrawal of an IND |
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Section 312.38
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General requirements for use of an investigational new drug in a clinical investigation |
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Section 312.40
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Comment and advice on an IND |
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Section 312.41
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Clinical holds and requests for modification |
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Section 312.42
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Termination |
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Section 312.44
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Inactive status |
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Section 312.45
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Meetings |
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Section 312.47
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Dispute resolution |
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Section 312.48
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General responsibilities of sponsors |
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Section 312.50
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Transfer of obligations to a contract research organization |
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Section 312.52
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Selecting investigators and monitors |
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Section 312.53
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Emergency research under Sec |
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Section 312.54
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Informing investigators |
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Section 312.55
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Review of ongoing investigations |
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Section 312.56
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Recordkeeping and record retention |
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Section 312.57
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Inspection of sponsor's records and reports |
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Section 312.58
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Disposition of unused supply of investigational drug |
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Section 312.59
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General responsibilities of investigators |
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Section 312.60
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Control of the investigational drug |
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Section 312.61
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Investigator recordkeeping and record retention |
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Section 312.62
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Investigator reports |
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Section 312.64
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Assurance of IRB review |
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Section 312.66
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Inspection of investigator's records and reports |
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Section 312.68
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Handling of controlled substances |
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Section 312.69
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Disqualification of a clinical investigator |
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Section 312.70
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Purpose |
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Section 312.80
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Scope |
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Section 312.81
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Early consultation |
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Section 312.82
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Treatment protocols |
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Section 312.83
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Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses |
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Section 312.84
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Phase 4 studies |
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Section 312.85
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Focused FDA regulatory research |
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Section 312.86
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Active monitoring of conduct and evaluation of clinical trials |
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Section 312.87
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Safeguards for patient safety |
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Section 312.88
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Import and export requirements |
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Section 312.110
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Foreign clinical studies not conducted under an IND |
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Section 312.120
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Availability for public disclosure of data and information in an IND |
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Section 312.130
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Address for correspondence |
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Section 312.140
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Guidance documents |
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Section 312.145
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Drugs for investigational use in laboratory research animals or in vitro tests |
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Section 312.160
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General |
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Section 312.300
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Requirements for all expanded access uses |
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Section 312.305
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Individual patients, including for emergency use |
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Section 312.310
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Intermediate-size patient populations |
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Section 312.315
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Treatment IND or treatment protocol |
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Section 312.320
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Scope of this part |