IND Exemptions for Studies of Lawfully Marketed Drug or Biological Products for the Treatment of Cancer: Guidance for Industry | Guideline Explorer

Description

This guidance is intended to assist sponsors in deciding whether a study of marketed drugs or biological products for treating cancer falls within the exemption under § 312.2(b)(1) (21 CFR312.2(b)(1)) from the general requirement to submit an investigational new drug application (IND). The guidance discusses the Agency's current thinking on when studies of marketed cancer products are exempt from IND regulation based on a risk assessment. The Agency hopes that clarifying its policy will help sponsors identify which studies are exempt, thus saving them from submitting unnecessary IND applications.

Scope & Applicability

Product Classes

5

resistance modulators

Initial studies of drugs intended to be resistance modulators

radiosensitizers

Initial studies of drugs intended to be radiosensitizers

chemosensitizers

Initial studies of drugs intended to be chemosensitizers

Cancer Drug

Marketed drug or biological products for the treatment of cancer.

Biological Products

Requires analytical comparability per ICH Q5E

Stakeholders

6

Manufacturer

Entity responsible for submitting NDINs

IRB

Institutional Review Board providing study approvals

Sponsor-investigator

Individual who both initiates and conducts an investigation.

Institutional Review Board

Governs top dose in clinical studies

Investigator

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

Sponsor

Entity responsible for submitting applications under section 524B

Regulatory Context

Attributes

2

Risk Assessment

Determining if an investigation significantly increases risk to patients.

Dosage Level

Specified quantity of a medicine to be taken at one time.

Identified Hazards

Hazards

1

Synergistic Toxicity

Enhanced effects from a new drug combination interfering with metabolism.; because of the possible occurrence of synergistic toxicity

Related CFR Sections (2)

21CFR312.2§ 312.2 Applicability.
(a) Applicability. Except as provided in this section, this part applies to all clinical investigations of products that are subject to section 505 of the Federal Food, Drug, and Cosmetic Act or to the licensing provisions of the Public Health Service Act (58 Stat. 632, as amended ( 42 U.S.C. 201 etRead full regulation →
21CFR312.7§ 312.7 Promotion of investigational drugs.
(a) Promotion of an investigational new drug. A sponsor or investigator, or any person acting on behalf of a sponsor or investigator, shall not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation or otherwise pRead full regulation →

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