Chapter 48 7348.809A Radioactive Drug Research Committee | Guideline Explorer

Scope & Applicability

Product Classes

2

Radioactive Drug

Includes radioactive biological products labeled with a radionuclide; Compounds with radionuclides used in research studies.; Drugs labeled with a radionuclide used in research.; Drugs labeled with radionuclides used in human research.; subject of the guidance and dose limits; Drugs used in basic science research under 21 CFR 361.1.; Subject of the RDRC review and checklist

Radioactive Biological Product

Biological products labeled with a radionuclide.

Stakeholders

9

Field Investigator

ORA personnel who conduct the inspections.; FDA personnel responsible for conducting inspections; Field personnel receiving training and operational guidance from OBIMO.

RDRC chairperson

Recipient of correspondence regarding the Center's assessment of performance.

Sponsor

Entity responsible for submitting applications under section 524B

Clinical Investigator

Veterinarian responsible for selecting anesthetic regimens and conducting field studies

Radioactive Drug Formulator

Required member of the RDRC quorum

Nuclear Medicine Physician

Required member of the RDRC quorum

Radioactive Drug Research Committee

committee that approves human research using radioactive drugs

Institutional Review Board

Governs top dose in clinical studies

Headquarters Participant

Member of the inspection team serving in a compliance or scientific advisory capacity

Regulatory Context

Attributes

2

Generally Recognized as Safe and Effective

Status (GRASE) of radioactive drugs reviewed by RDRCs.

Quorum

Requirement of more than 50% membership present for official meetings

Identified Hazards

Hazards

1

Radiation Exposure

Risk that may pose a safety concern to users; Risks from lasers or radiation exposure.

Related CFR Sections (4)

21CFR361.1§ 361.1 Radioactive drugs for certain research uses.
(a) Radioactive drugs (as defined in § 310.3(n) of this chapter ) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic informationRead full regulation →
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 →
21CFR310.3§ 310.3 Definitions and interpretations.
As used in this part:Read full regulation →
21CFR201.129§ 201.129 Drugs; exemption for radioactive drugs for research use.
A radioactive drug intended for administration to human research subjects during the course of a research project intended to obtain basic research information regarding metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, patRead full regulation →

Related Warning Letters (10)

Clinical Investigator
Shirish M. Gadgeel, M.D.
2025-09-09
Clinical Investigator
Mark J. Savant, M.D
2025-07-15
Bioresearch Monitoring Program/Institutional Review Board (IRB)
United Health Products, Inc.
2025-05-20
Clinical Investigator
Americo F. Padilla, M.D.
2025-03-25
Institutional Review Board (IRB)
Armstrong County Memorial Hospital
2024-11-05
Clinical Investigator
Namita A. Goyal, M.D.
2024-10-22
Institutional Review Board (IRB)
Louisiana State University Health Science Center IRB
2024-10-08
Bioresearch Monitoring Program/IRB
Massachusetts Institute of Technology MIT
2024-07-16
Clinical Investigator (Sponsor)
Angela D. Ritter, M.D.
2024-06-18
Institutional Review Board (IRB)
New York State Psychiatric Institute IRB
2024-03-26