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- 21 CFR 312.2 · Applicability.
- 21 CFR 312.3 · Definitions and interpretations.
- 21 CFR 312.6 · Labeling of an investigational new drug.
- 21 CFR 312.7 · Promotion of investigational drugs.
- 21 CFR 312.8 · Charging for investigational drugs under an IND.
- 21 CFR 312.10 · Waivers.
- 21 CFR 312.20 · Requirement for an IND.
- 21 CFR 312.21 · Phases of an investigation.
- 21 CFR 312.22 · General principles of the IND submission.
- 21 CFR 312.23 · IND content and format.
- 21 CFR 312.30 · Protocol amendments.
- 21 CFR 312.31 · Information amendments.
- 21 CFR 312.32 · IND safety reporting.
- 21 CFR 312.33 · Annual reports.
- 21 CFR 312.38 · Withdrawal of an IND.
- 21 CFR 312.40 · General requirements for use of an investigational new drug in a clinical investigation.
- 21 CFR 312.41 · Comment and advice on an IND.
- 21 CFR 312.42 · Clinical holds and requests for modification.
- 21 CFR 312.44 · Termination.
- 21 CFR 312.45 · Inactive status.
- 21 CFR 312.47 · Meetings.
- 21 CFR 312.48 · Dispute resolution.
- 21 CFR 312.50 · General responsibilities of sponsors.
- 21 CFR 312.52 · Transfer of obligations to a contract research organization.
- 21 CFR 312.53 · Selecting investigators and monitors.
- 21 CFR 312.54 · Emergency research under § 50.24 of this chapter.
- 21 CFR 312.55 · Informing investigators.
- 21 CFR 312.56 · Review of ongoing investigations.
- 21 CFR 312.57 · Recordkeeping and record retention.
- 21 CFR 312.58 · Inspection of sponsor's records and reports.
- 21 CFR 312.59 · Disposition of unused supply of investigational drug.
- 21 CFR 312.60 · General responsibilities of investigators.
- 21 CFR 312.61 · Control of the investigational drug.
- 21 CFR 312.62 · Investigator recordkeeping and record retention.
- 21 CFR 312.64 · Investigator reports.
- 21 CFR 312.66 · Assurance of IRB review.
- 21 CFR 312.68 · Inspection of investigator's records and reports.
- 21 CFR 312.69 · Handling of controlled substances.
- 21 CFR 312.70 · Disqualification of a clinical investigator.
- 21 CFR 312.80 · Purpose.
- 21 CFR 312.81 · Scope.
- 21 CFR 312.82 · Early consultation.
- 21 CFR 312.83 · Treatment protocols.
- 21 CFR 312.84 · Risk-benefit analysis in review of marketing applications for drugs to treat life-threatening and severely-debilitating illnesses.
- 21 CFR 312.85 · Phase 4 studies.
- 21 CFR 312.86 · Focused FDA regulatory research.
- 21 CFR 312.87 · Active monitoring of conduct and evaluation of clinical trials.
- 21 CFR 312.88 · Safeguards for patient safety.
- 21 CFR 312.110 · Import and export requirements.
- 21 CFR 312.120 · Foreign clinical studies not conducted under an IND.
- 21 CFR 312.130 · Availability for public disclosure of data and information in an IND.
- 21 CFR 312.140 · Address for correspondence.
- 21 CFR 312.145 · Guidance documents.
- 21 CFR 312.160 · Drugs for investigational use in laboratory research animals or in vitro tests.
- 21 CFR 312.300 · General.
- 21 CFR 312.305 · Requirements for all expanded access uses.
- 21 CFR 312.310 · Individual patients, including for emergency use.
- 21 CFR 312.315 · Intermediate-size patient populations.
- 21 CFR 312.320 · Treatment IND or treatment protocol.
- 21 CFR 314.1 · Scope of this part.
- 21 CFR 314.2 · Purpose.
- 21 CFR 314.3 · Definitions.
- 21 CFR 314.50 · Content and format of an NDA.
- 21 CFR 314.52 · Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
- 21 CFR 314.53 · Submission of patent information.
- 21 CFR 314.54 · Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug.
- 21 CFR 314.55 · Pediatric use information.
- 21 CFR 314.56 · Nonprescription drug product with an additional condition for nonprescription use (ACNU).
- 21 CFR 314.60 · Amendments to an unapproved NDA, supplement, or resubmission.
- 21 CFR 314.65 · Withdrawal by the applicant of an unapproved application.
- 21 CFR 314.70 · Supplements and other changes to an approved NDA.
- 21 CFR 314.71 · Procedures for submission of a supplement to an approved application.
- 21 CFR 314.72 · Change in ownership of an application.
- 21 CFR 314.80 · Postmarketing reporting of adverse drug experiences.
- 21 CFR 314.81 · Other postmarketing reports.
- 21 CFR 314.90 · Waivers.
- 21 CFR 314.92 · Drug products for which abbreviated applications may be submitted.
- 21 CFR 314.93 · Petition to request a change from a listed drug.
- 21 CFR 314.94 · Content and format of an ANDA.
- 21 CFR 314.95 · Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
- 21 CFR 314.96 · Amendments to an unapproved ANDA.
- 21 CFR 314.97 · Supplements and other changes to an approved ANDA.
- 21 CFR 314.98 · Postmarketing reports.
- 21 CFR 314.99 · Other responsibilities of an applicant of an ANDA.
- 21 CFR 314.100 · Timeframes for reviewing applications and abbreviated applications.
- 21 CFR 314.101 · Filing an NDA and receiving an ANDA.
- 21 CFR 314.102 · Communications between FDA and applicants.
- 21 CFR 314.103 · Dispute resolution.
- 21 CFR 314.104 · Drugs with potential for abuse.
- 21 CFR 314.105 · Approval of an NDA and an ANDA.
- 21 CFR 314.106 · Foreign data.
- 21 CFR 314.107 · Date of approval of a 505(b)(2) application or ANDA.
- 21 CFR 314.108 · New drug product exclusivity.
- 21 CFR 314.110 · Complete response letter to the applicant.
- 21 CFR 314.120 · [Reserved]
- 21 CFR 314.122 · Submitting an abbreviated application for, or a 505(j)(2)(C) petition that relies on, a listed drug that is no longer marketed.
- 21 CFR 314.125 · Refusal to approve an NDA.
- 21 CFR 314.126 · Adequate and well-controlled studies.
- 21 CFR 314.127 · Refusal to approve an ANDA.
- 21 CFR 314.150 · Withdrawal of approval of an application or abbreviated application.