• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER D--DRUGS FOR HUMAN USE
 
PART 312INVESTIGATIONAL NEW DRUG APPLICATION
 

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.

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.

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.

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.

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.

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.

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
   § 312.300 - 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.

Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360bbb, 371; 42 U.S.C. 262.
Source: 52 FR 8831, Mar. 19, 1987, unless otherwise noted.

-
-