TITLE 21--FOOD AND DRUGS 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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