Title 21

PART 312

Part 312 - Investigational New Drug Application

PART 312 - INVESTIGATIONAL NEW DRUG APPLICATION 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.

21:5.0.1.1.3.1SUBPART A
Subpart A - General Provisions
21:5.0.1.1.3.1.1.1SECTION 312.1
   312.1 Scope.
21:5.0.1.1.3.1.1.2SECTION 312.2
   312.2 Applicability.
21:5.0.1.1.3.1.1.3SECTION 312.3
   312.3 Definitions and interpretations.
21:5.0.1.1.3.1.1.4SECTION 312.6
   312.6 Labeling of an investigational new drug.
21:5.0.1.1.3.1.1.5SECTION 312.7
   312.7 Promotion of investigational drugs.
21:5.0.1.1.3.1.1.6SECTION 312.8
   312.8 Charging for investigational drugs under an IND.
21:5.0.1.1.3.1.1.7SECTION 312.10
   312.10 Waivers.
21:5.0.1.1.3.2SUBPART B
Subpart B - Investigational New Drug Application (IND)
21:5.0.1.1.3.2.1.1SECTION 312.20
   312.20 Requirement for an IND.
21:5.0.1.1.3.2.1.2SECTION 312.21
   312.21 Phases of an investigation.
21:5.0.1.1.3.2.1.3SECTION 312.22
   312.22 General principles of the IND submission.
21:5.0.1.1.3.2.1.4SECTION 312.23
   312.23 IND content and format.
21:5.0.1.1.3.2.1.5SECTION 312.30
   312.30 Protocol amendments.
21:5.0.1.1.3.2.1.6SECTION 312.31
   312.31 Information amendments.
21:5.0.1.1.3.2.1.7SECTION 312.32
   312.32 IND safety reporting.
21:5.0.1.1.3.2.1.8SECTION 312.33
   312.33 Annual reports.
21:5.0.1.1.3.2.1.9SECTION 312.38
   312.38 Withdrawal of an IND.
21:5.0.1.1.3.3SUBPART C
Subpart C - Administrative Actions
21:5.0.1.1.3.3.1.1SECTION 312.40
   312.40 General requirements for use of an investigational new drug in a clinical investigation.
21:5.0.1.1.3.3.1.2SECTION 312.41
   312.41 Comment and advice on an IND.
21:5.0.1.1.3.3.1.3SECTION 312.42
   312.42 Clinical holds and requests for modification.
21:5.0.1.1.3.3.1.4SECTION 312.44
   312.44 Termination.
21:5.0.1.1.3.3.1.5SECTION 312.45
   312.45 Inactive status.
21:5.0.1.1.3.3.1.6SECTION 312.47
   312.47 Meetings.
21:5.0.1.1.3.3.1.7SECTION 312.48
   312.48 Dispute resolution.
21:5.0.1.1.3.4SUBPART D
Subpart D - Responsibilities of Sponsors and Investigators
21:5.0.1.1.3.4.1.1SECTION 312.50
   312.50 General responsibilities of sponsors.
21:5.0.1.1.3.4.1.2SECTION 312.52
   312.52 Transfer of obligations to a contract research organization.
21:5.0.1.1.3.4.1.3SECTION 312.53
   312.53 Selecting investigators and monitors.
21:5.0.1.1.3.4.1.4SECTION 312.54
   312.54 Emergency research under § 50.24 of this chapter.
21:5.0.1.1.3.4.1.5SECTION 312.55
   312.55 Informing investigators.
21:5.0.1.1.3.4.1.6SECTION 312.56
   312.56 Review of ongoing investigations.
21:5.0.1.1.3.4.1.7SECTION 312.57
   312.57 Recordkeeping and record retention.
21:5.0.1.1.3.4.1.8SECTION 312.58
   312.58 Inspection of sponsor's records and reports.
21:5.0.1.1.3.4.1.9SECTION 312.59
   312.59 Disposition of unused supply of investigational drug.
21:5.0.1.1.3.4.1.10SECTION 312.60
   312.60 General responsibilities of investigators.
21:5.0.1.1.3.4.1.11SECTION 312.61
   312.61 Control of the investigational drug.
21:5.0.1.1.3.4.1.12SECTION 312.62
   312.62 Investigator recordkeeping and record retention.
21:5.0.1.1.3.4.1.13SECTION 312.64
   312.64 Investigator reports.
21:5.0.1.1.3.4.1.14SECTION 312.66
   312.66 Assurance of IRB review.
21:5.0.1.1.3.4.1.15SECTION 312.68
   312.68 Inspection of investigator's records and reports.
21:5.0.1.1.3.4.1.16SECTION 312.69
   312.69 Handling of controlled substances.
21:5.0.1.1.3.4.1.17SECTION 312.70
   312.70 Disqualification of a clinical investigator.
21:5.0.1.1.3.5SUBPART E
Subpart E - Drugs Intended to Treat Life-threatening and Severely-debilitating Illnesses
21:5.0.1.1.3.5.1.1SECTION 312.80
   312.80 Purpose.
21:5.0.1.1.3.5.1.2SECTION 312.81
   312.81 Scope.
21:5.0.1.1.3.5.1.3SECTION 312.82
   312.82 Early consultation.
21:5.0.1.1.3.5.1.4SECTION 312.83
   312.83 Treatment protocols.
21:5.0.1.1.3.5.1.5SECTION 312.84
   312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
21:5.0.1.1.3.5.1.6SECTION 312.85
   312.85 Phase 4 studies.
21:5.0.1.1.3.5.1.7SECTION 312.86
   312.86 Focused FDA regulatory research.
21:5.0.1.1.3.5.1.8SECTION 312.87
   312.87 Active monitoring of conduct and evaluation of clinical trials.
21:5.0.1.1.3.5.1.9SECTION 312.88
   312.88 Safeguards for patient safety.
21:5.0.1.1.3.6SUBPART F
Subpart F - Miscellaneous
21:5.0.1.1.3.6.1.1SECTION 312.110
   312.110 Import and export requirements.
21:5.0.1.1.3.6.1.2SECTION 312.120
   312.120 Foreign clinical studies not conducted under an IND.
21:5.0.1.1.3.6.1.3SECTION 312.130
   312.130 Availability for public disclosure of data and information in an IND.
21:5.0.1.1.3.6.1.4SECTION 312.140
   312.140 Address for correspondence.
21:5.0.1.1.3.6.1.5SECTION 312.145
   312.145 Guidance documents.
21:5.0.1.1.3.7SUBPART G
Subpart G - Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
21:5.0.1.1.3.7.1.1SECTION 312.160
   312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
21:5.0.1.1.3.8SUBPART H
Subpart H [Reserved]
21:5.0.1.1.3.9SUBPART I
Subpart I - Expanded Access to Investigational Drugs for Treatment Use
21:5.0.1.1.3.9.1.1SECTION 312.300
   312.300 General.
21:5.0.1.1.3.9.1.2SECTION 312.305
   312.305 Requirements for all expanded access uses.
21:5.0.1.1.3.9.1.3SECTION 312.310
   312.310 Individual patients, including for emergency use.
21:5.0.1.1.3.9.1.4SECTION 312.315
   312.315 Intermediate-size patient populations.
21:5.0.1.1.3.9.1.5SECTION 312.320
   312.320 Treatment IND or treatment protocol.