Part 312 — Investigational New Drug Application
Subpart A — General Provisions
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
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.