21 CFR
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 9 × 483
- § 312.7 Promotion of investigational drugs 3 × 483
- § 312.8 Charging for investigational drugs under an IND 1 × 483
- § 312.10 Waivers
Subpart B - Investigational New Drug Application (IND)
- § 312.20 Requirement for an IND 30 × 483
- § 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
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 261 × 483
- § 312.52 Transfer of obligations to a contract research organization 15 × 483
- § 312.53 Selecting investigators and monitors 67 × 483
- § 312.54 Emergency research under § 50.24 of this chapter
- § 312.55 Informing investigators 11 × 483
- § 312.56 Review of ongoing investigations 97 × 483
- § 312.57 Recordkeeping and record retention 45 × 483
- § 312.58 Inspection of sponsor's records and reports 5 × 483
- § 312.59 Disposition of unused supply of investigational drug 19 × 483
- § 312.60 General responsibilities of investigators 2,170 × 483
- § 312.61 Control of the investigational drug 17 × 483
- § 312.62 Investigator recordkeeping and record retention 1,616 × 483
- § 312.64 Investigator reports 181 × 483
- § 312.66 Assurance of IRB review 306 × 483
- § 312.68 Inspection of investigator's records and reports 9 × 483
- § 312.69 Handling of controlled substances 3 × 483
- § 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 5 × 483
- § 312.130 Availability for public disclosure of data and information in an IND
- § 312.140 Address for correspondence
- § 312.145 Guidance documents