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FEDERAL · 21 CFR

Part 312 — Investigational New Drug Application

60 sections · Title 21: Food and Drugs

§ 312.1Scope.
§ 312.2Applicability.
§ 312.3Definitions and interpretations.
§ 312.6Labeling of an investigational new drug.
§ 312.7Promotion of investigational drugs.
§ 312.8Charging for investigational drugs under an IND.
§ 312.10Waivers.
§ 312.20Requirement for an IND.
§ 312.21Phases of an investigation.
§ 312.22General principles of the IND submission.
§ 312.23IND content and format.
§ 312.30Protocol amendments.
§ 312.31Information amendments.
§ 312.32IND safety reporting.
§ 312.33Annual reports.
§ 312.38Withdrawal of an IND.
§ 312.40General requirements for use of an investigational new drug in a clinical investigation.
§ 312.41Comment and advice on an IND.
§ 312.42Clinical holds and requests for modification.
§ 312.44Termination.
§ 312.45Inactive status.
§ 312.47Meetings.
§ 312.48Dispute resolution.
§ 312.50General responsibilities of sponsors.
§ 312.52Transfer of obligations to a contract research organization.
§ 312.53Selecting investigators and monitors.
§ 312.54Emergency research under § 50.24 of this chapter.
§ 312.55Informing investigators.
§ 312.56Review of ongoing investigations.
§ 312.57Recordkeeping and record retention.
§ 312.58Inspection of sponsor's records and reports.
§ 312.59Disposition of unused supply of investigational drug.
§ 312.60General responsibilities of investigators.
§ 312.61Control of the investigational drug.
§ 312.62Investigator recordkeeping and record retention.
§ 312.64Investigator reports.
§ 312.66Assurance of IRB review.
§ 312.68Inspection of investigator's records and reports.
§ 312.69Handling of controlled substances.
§ 312.70Disqualification of a clinical investigator.
§ 312.80Purpose.
§ 312.81Scope.
§ 312.82Early consultation.
§ 312.83Treatment protocols.
§ 312.84Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
§ 312.85Phase 4 studies.
§ 312.86Focused FDA regulatory research.
§ 312.87Active monitoring of conduct and evaluation of clinical trials.
§ 312.88Safeguards for patient safety.
§ 312.110Import and export requirements.
§ 312.120Foreign clinical studies not conducted under an IND.
§ 312.130Availability for public disclosure of data and information in an IND.
§ 312.140Address for correspondence.
§ 312.145Guidance documents.
§ 312.160Drugs for investigational use in laboratory research animals or in vitro tests.
§ 312.300General.
§ 312.305Requirements for all expanded access uses.
§ 312.310Individual patients, including for emergency use.
§ 312.315Intermediate-size patient populations.
§ 312.320Treatment IND or treatment protocol.