Part 312 — Investigational New Drug Application
Current through Sep 8, 2026
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.
Editorial Note: Nomenclature changes to part 312 appear at 69 FR 13717, Mar. 24, 2004.
Sections
- § 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.
- § 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.
- § 312.38 Withdrawal of an IND.
- § 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.
- § 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.
- § 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.
- § 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.
- § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
- § 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.