From: Subject: 1999 CFR Title 21, Volume 1 Date: Tue, 7 Nov 2006 17:24:30 -0500 MIME-Version: 1.0 Content-Type: multipart/related; boundary="----=_NextPart_000_0000_01C70291.95CB4A70"; type="text/html" X-MimeOLE: Produced By Microsoft MimeOLE V6.00.2800.1807 This is a multi-part message in MIME format. ------=_NextPart_000_0000_01C70291.95CB4A70 Content-Type: text/html; charset="Windows-1252" Content-Transfer-Encoding: quoted-printable Content-Location: http://www.access.gpo.gov/nara/cfr/waisidx_99/21cfr312_99.html 1999 CFR Title 21, Volume 1

Title 21--Food and = Drugs

CHAPTER I--FOOD AND DRUG = ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES =

PART 312--INVESTIGATIONAL NEW DRUG APPLICATION

312.1 Scope.
312.2 Applicability.
312.3 Definitions and interpretations.
312.6 Labeling of an investigational new drug.
312.7 Promotion and charging for investigational drugs.
312.10 Waivers.
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 reports.
312.33 Annual reports.
312.34 Treatment use of an investigational new drug.
312.35 Submissions for treatment use.
312.36 Emergency use of an investigational new drug.
312.38 Withdrawal of an IND.
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.
312.42 Clinical holds and requests for modification.
312.44 Termination.
312.45 Inactive status.
312.47 Meetings.
312.48 Dispute resolution.
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.
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=20 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.
312.110 Import and export requirements.
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.=20
312.140 Address for correspondence.
312.145 Guidelines.
312.160 Drugs for investigational use in laboratory research animals or = in=20 vitro tests.

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