21 CFR Part 312 for Investigational New Drug Application

Sathyanarayana M.Sc.


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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.

21 CFR Part 312 for Investigational New Drug Application:

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