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Title 21 - Title 21

Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

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Details about Part 312

Description

DRUGS FOR HUMAN USE - INVESTIGATIONAL NEW DRUG APPLICATION

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60 sections

§312.1 - Scope.

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§312.10 - Waivers.

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§312.110 - Import and export requirements.

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§312.120 - Foreign clinical studies not conducted under an IND.

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§312.130 - Availability for public disclosure of data and information in an IND.

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§312.140 - Address for correspondence.

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§312.145 - Guidance documents.

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§312.160 - Drugs for investigational use in laboratory research animals or in vitro tests.

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§312.2 - Applicability.

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§312.20 - Requirement for an IND.

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§312.21 - Phases of an investigation.

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§312.22 - General principles of the IND submission.

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§312.23 - IND content and format.

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§312.3 - Definitions and interpretations.

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§312.30 - Protocol amendments.

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§312.300 - General.

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§312.305 - Requirements for all expanded access uses.

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§312.31 - Information amendments.

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§312.310 - Individual patients, including for emergency use.

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§312.315 - Intermediate-size patient populations.

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§312.32 - IND safety reporting.

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§312.320 - Treatment IND or treatment protocol.

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§312.33 - Annual reports.

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§312.38 - Withdrawal of an IND.

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§312.40 - General requirements for use of an investigational new drug in a clinical investigation.

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§312.41 - Comment and advice on an IND.

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§312.42 - Clinical holds and requests for modification.

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§312.44 - Termination.

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§312.45 - Inactive status.

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§312.47 - Meetings.

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§312.48 - Dispute resolution.

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§312.50 - General responsibilities of sponsors.

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§312.52 - Transfer of obligations to a contract research organization.

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§312.53 - Selecting investigators and monitors.

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§312.54 - Emergency research under § 50.24 of this chapter.

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§312.55 - Informing investigators.

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§312.56 - Review of ongoing investigations.

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§312.57 - Recordkeeping and record retention.

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§312.58 - Inspection of sponsor's records and reports.

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§312.59 - Disposition of unused supply of investigational drug.

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§312.6 - Labeling of an investigational new drug.

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§312.60 - General responsibilities of investigators.

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§312.61 - Control of the investigational drug.

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§312.62 - Investigator recordkeeping and record retention.

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§312.64 - Investigator reports.

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§312.66 - Assurance of IRB review.

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§312.68 - Inspection of investigator's records and reports.

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§312.69 - Handling of controlled substances.

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§312.7 - Promotion of investigational drugs.

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§312.70 - Disqualification of a clinical investigator.

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§312.8 - Charging for investigational drugs under an IND.

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§312.80 - Purpose.

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§312.81 - Scope.

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§312.82 - Early consultation.

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§312.83 - Treatment protocols.

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§312.84 - Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.

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§312.85 - Phase 4 studies.

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§312.86 - Focused FDA regulatory research.

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§312.87 - Active monitoring of conduct and evaluation of clinical trials.

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§312.88 - Safeguards for patient safety.

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