Description
On April 28, 2008, the Food and Drug Administration (FDA or Agency) amended its regulations on the acceptance of foreign clinical studies not conducted under an investigational new drug application (IND) (“non-IND foreign clinical studies”) as support for an IND or a new drug application (NDA), abbreviated new drug application (ANDA), or a biologics license application (BLA) (collectively known as “marketing applications” or “applications for marketing approval”).2 The final rule requires that such studies be conducted in accordance with good clinical practice (GCP), including review and approval by an independent ethics committee (IEC) and informed consent from subjects. The GCP requirements in the final rule encompass both ethical and data integrity standards for clinical studies. This final rule, which took effect on October 27, 2008, is codified at 21 CFR 312.120. It is intended to help ensure the protection of human subjects enrolled in non-IND foreign clinical studies as well as the quality and integrity of the resulting data.
Scope & Applicability
Stakeholders
6Entity responsible for submitting applications under section 524B
Independent Ethics Committee listed in eCTD documentation
Entity submitting development data and knowledge; Entity performing the work process for change
Responsible for qualifications, training, and trial conduct; Individual responsible for trial conduct and data governance at a site.; May delegate tasks but retains overall responsibility; Person responsible for the conduct of the clinical trial at a trial site; Responsible for trial conduct and participant safety; Responsible for trial conduct, data integrity, and investigational product management.; Individual responsible for trial conduct at a site and informing the institution.; maintaining
Responsible for submission and communication oversight; Safeguard the rights, safety and well-being of trial participants; Reviewing trial conduct and records
Veterinarian responsible for selecting anesthetic regimens and conducting field studies
Regulatory Context
Attributes
1Records must be kept for at least 2 years after Agency decision
Related CFR Sections (6)
- 21CFR312.120§ 312.120 Foreign clinical studies not conducted under an IND.
(a) Acceptance of studies.Read full regulation →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
- 21CFR312.3§ 312.3 Definitions and interpretations.
(a) The definitions and interpretations of terms contained in section 201 of the Act apply to those terms when used in this part:Read full regulation →
- 21CFR314.106§ 314.106 Foreign data.
(a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this chapter .Read full regulation →
- 21CFR56.102§ 56.102 Definitions.
As used in this part:Read full regulation →
- 21CFR56.107§ 56.107 IRB membership.
(a) Each IRB shall have at least five members, with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. The IRB shall be sufficiently qualified through the experience and expertise of its members, and the diversity of the members,Read full regulation →
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- 2025-12-09
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- 2025-11-18
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Verdure Sciences, Inc.
- 2025-09-30
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See Also (8)
- Study Data Technical Conformance Guide - Technical Specifications Document (Status: Final)
- PHS Guideline on Infectious Disease Issues in Xenotransplantation: PHS Guideline (Status: Final)
- Developing Medical Imaging Drug and Biological Products Part 2: Clinical Indications (Status: Final)
- FDA Review of Vaccine Labeling Requirements for Warnings, Use Instructions, and Precautionary Information: Guidance for Industry (Status: Final)
- Pharmacogenomic Data Submissions: Guidance for Industry (Status: Final)
- Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials: Guidance for Industry (Status: Final)
- Considerations for Plasmid DNA Vaccines for Infectious Disease Indications: Guidance for Industry (Status: Final)
- Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information (Status: Final)