21 CFR Part 312
PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
- PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
- Chapter I—Food and Drug Administration, Department of Health and Human Services › Subchapter D—Drugs for Human Use
- Subpart A—General Provisions
- § 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.
- Subpart B—Investigational New Drug Application (IND)
- § 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.
- 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.
- § 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.
- 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.
- § 312.130 Availability for public disclosure of data and information in an IND.
- § 312.140 Address for correspondence.
- § 312.145 Guidance documents.
- Subpart G—Drugs for Investigational Use in Laboratory Research Animals or In Vitro Tests
- § 312.160 Drugs for investigational use in laboratory research animals or in vitro tests.
- Subpart H [Reserved]
- Subpart I—Expanded Access to Investigational Drugs for Treatment Use
- § 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.
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