Title 21--Food and Drugs

CHAPTER I--FOOD AND DRUG ADMINISTRATION,
DEPARTMENT OF HEALTH AND HUMAN SERVICES

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

TEXT PDF312.1 Scope.
TEXT PDF312.2 Applicability.
TEXT PDF312.3 Definitions and interpretations.
TEXT PDF312.6 Labeling of an investigational new drug.
TEXT PDF312.7 Promotion and charging for investigational drugs.
TEXT PDF312.10 Waivers.
TEXT PDF312.20 Requirement for an IND.
TEXT PDF312.21 Phases of an investigation.
TEXT PDF312.22 General principles of the IND submission.
TEXT PDF312.23 IND content and format.
TEXT PDF312.30 Protocol amendments.
TEXT PDF312.31 Information amendments.
TEXT PDF312.32 IND safety reports.
TEXT PDF312.32 IND safety reports.
TEXT PDF312.33 Annual reports.
TEXT PDF312.33 Annual reports.
TEXT PDF312.34 Treatment use of an investigational new drug.
TEXT PDF312.35 Submissions for treatment use.
TEXT PDF312.36 Emergency use of an investigational new drug.
TEXT PDF312.38 Withdrawal of an IND.
TEXT PDF312.40 General requirements for use of an investigational new drug in a clinical investigation.
TEXT PDF312.41 Comment and advice on an IND.
TEXT PDF312.42 Clinical holds and requests for modification.
TEXT PDF312.44 Termination.
TEXT PDF312.45 Inactive status.
TEXT PDF312.47 Meetings.
TEXT PDF312.48 Dispute resolution.
TEXT PDF312.50 General responsibilities of sponsors.
TEXT PDF312.52 Transfer of obligations to a contract research organization.
TEXT PDF312.53 Selecting investigators and monitors.
TEXT PDF312.54 Emergency research under 50.24 of this chapter.
TEXT PDF312.55 Informing investigators.
TEXT PDF312.56 Review of ongoing investigations.
TEXT PDF312.57 Recordkeeping and record retention.
TEXT PDF312.58 Inspection of sponsor's records and reports.
TEXT PDF312.59 Disposition of unused supply of investigational drug.
TEXT PDF312.60 General responsibilities of investigators.
TEXT PDF312.61 Control of the investigational drug.
TEXT PDF312.62 Investigator recordkeeping and record retention.
TEXT PDF312.64 Investigator reports.
TEXT PDF312.66 Assurance of IRB review.
TEXT PDF312.68 Inspection of investigator's records and reports.
TEXT PDF312.69 Handling of controlled substances.
TEXT PDF312.70 Disqualification of a clinical investigator.
TEXT PDF312.80 Purpose.
TEXT PDF312.81 Scope.
TEXT PDF312.82 Early consultation.
TEXT PDF312.83 Treatment protocols.
TEXT PDF312.84 Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
TEXT PDF312.85 Phase 4 studies.
TEXT PDF312.86 Focused FDA regulatory research.
TEXT PDF312.87 Active monitoring of conduct and evaluation of clinical trials.
TEXT PDF312.88 Safeguards for patient safety.
TEXT PDF312.110 Import and export requirements.
TEXT PDF312.120 Foreign clinical studies not conducted under an IND.
TEXT PDF312.130 Availability for public disclosure of data and information in an IND.
TEXT PDF312.140 Address for correspondence.
TEXT PDF312.145 Guidelines.
TEXT PDF312.160 Drugs for investigational use in laboratory research animals or in vitro tests.

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