Title 21, Part 312 — Investigational New Drug Application
60 sections
Section 312.1
Scope.
Section 312.2
Applicability.
Section 312.3
Definitions and interpretations.
Section 312.6
Labeling of an investigational new drug.
Section 312.7
Promotion of investigational drugs.
Section 312.8
Charging for investigational drugs under an IND.
Section 312.10
Waivers.
Section 312.20
Requirement for an IND.
Section 312.21
Phases of an investigation.
Section 312.22
General principles of the IND submission.
Section 312.23
IND content and format.
Section 312.30
Protocol amendments.
Section 312.31
Information amendments.
Section 312.32
IND safety reporting.
Section 312.33
Annual reports.
Section 312.38
Withdrawal of an IND.
Section 312.40
General requirements for use of an investigational new drug in a clinical investigation.
Section 312.41
Comment and advice on an IND.
Section 312.42
Clinical holds and requests for modification.
Section 312.44
Termination.
Section 312.45
Inactive status.
Section 312.47
Meetings.
Section 312.48
Dispute resolution.
Section 312.50
General responsibilities of sponsors.
Section 312.52
Transfer of obligations to a contract research organization.
Section 312.53
Selecting investigators and monitors.
Section 312.54
Emergency research under § 50.24 of this chapter.
Section 312.55
Informing investigators.
Section 312.56
Review of ongoing investigations.
Section 312.57
Recordkeeping and record retention.
Section 312.58
Inspection of sponsor's records and reports.
Section 312.59
Disposition of unused supply of investigational drug.
Section 312.60
General responsibilities of investigators.
Section 312.61
Control of the investigational drug.
Section 312.62
Investigator recordkeeping and record retention.
Section 312.64
Investigator reports.
Section 312.66
Assurance of IRB review.
Section 312.68
Inspection of investigator's records and reports.
Section 312.69
Handling of controlled substances.
Section 312.70
Disqualification of a clinical investigator.
Section 312.80
Purpose.
Section 312.81
Scope.
Section 312.82
Early consultation.
Section 312.83
Treatment protocols.
Section 312.84
Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
Section 312.85
Phase 4 studies.
Section 312.86
Focused FDA regulatory research.
Section 312.87
Active monitoring of conduct and evaluation of clinical trials.
Section 312.88
Safeguards for patient safety.
Section 312.110
Import and export requirements.
Section 312.120
Foreign clinical studies not conducted under an IND.
Section 312.130
Availability for public disclosure of data and information in an IND.
Section 312.140
Address for correspondence.
Section 312.145
Guidance documents.
Section 312.160
Drugs for investigational use in laboratory research animals or in vitro tests.
Section 312.300
General.
Section 312.305
Requirements for all expanded access uses.
Section 312.310
Individual patients, including for emergency use.
Section 312.315
Intermediate-size patient populations.
Section 312.320
Treatment IND or treatment protocol.