21 CFR PART 312—INVESTIGATIONAL NEW DRUG APPLICATION
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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.
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.
312.31 Information
amendments.
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.
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.
312.66 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
312.86 Focused FDA
regulatory research.
312.87 Active
monitoring of conduct and evaluation of clinical trials.
312.88 Safeguards
for patient safety.
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.
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
312.305
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:
