21 C.F.R. PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
PART 312--INVESTIGATIONAL NEW DRUG APPLICATION
Subpart A--GENERAL PROVISIONS
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| Definitions and interpretations.
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| Labeling of an investigational new drug.
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| Promotion and charging for investigational drugs.
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Subpart B--INVESTIGATIONAL NEW DRUG APPLICATION (IND)
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| Phases of an investigation.
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| General principles of the IND submission.
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| Treatment use of an investigational new drug.
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| Submissions for treatment use.
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| Emergency use of an investigational new drug (IND).
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Subpart C--ADMINISTRATIVE ACTIONS
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| General requirements for use of an investigational new drug in a clinical investigation.
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| Comment and advice on an IND.
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| Clinical holds and requests for modification.
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Subpart D--RESPONSIBILITIES OF SPONSORS AND INVESTIGATORS
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| General responsibilities of sponsors.
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| Transfer of obligations to a contract research organization.
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| Selecting investigators and monitors.
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| Emergency research under 50.24 of this chapter.
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| Review of ongoing investigations.
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| Recordkeeping and record retention.
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| Inspection of sponsor's records and reports.
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| Disposition of unused supply of investigational drug.
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| General responsibilities of investigators.
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| Control of the investigational drug.
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| Investigator recordkeeping and record retention.
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| Inspection of investigator's records and reports.
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| Handling of controlled substances.
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| Disqualification of a clinical investigator.
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Subpart E--DRUGS INTENDED TO TREAT LIFE-THREATENING AND SEVERELY-DEBILITATING ILLNESSES
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| Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
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| Focused FDA regulatory research.
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| Active monitoring of conduct and evaluation of clinical trials.
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| Safeguards for patient safety.
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Subpart F--MISCELLANEOUS
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| Import and export requirements.
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| Foreign clinical studies not conducted under an IND.
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| Availability for public disclosure of data and information in an IND.
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| Address for correspondence.
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Subpart G--DRUGS FOR INVESTIGATIONAL USE IN LABORATORY RESEARCH ANIMALS OR IN VITRO TESTS
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| Drugs for investigational use in laboratory research animals or in vitro tests.
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