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Electronic Code of Federal Regulations

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e-CFR Data is current as of September 29, 2014

Title 21Chapter ISubchapter DPart 312


TITLE 21—Food and Drugs

CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)

SUBCHAPTER D—DRUGS FOR HUMAN USE

PART 312—INVESTIGATIONAL NEW DRUG APPLICATION

rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

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.
rule

Subpart H—[RESERVED]

rule

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.


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