Do Radioactive Drug Research Committees (RDRCs) have authority to approve initial clinical studies in lieu of an IND?

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No. An IND is required when the purpose of the study is to determine safety and efficacy of the drug or for immediate therapeutic, diagnostic or similar purposes. RDRCs are provided for in 21 CFR 361.1 Radioactive Drugs for Certain Research Uses. Radioactive drugs may be administered to human research subjects without obtaining an IND when the purpose of the research project is to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a radioactively labelled drug or regarding human physiology, pathophysiology, or biochemistry. Certain basic research studies, such as studies to determine whether a drug localizes in a particular organ or fluid space and to describe the kinetics of that localization, may have eventual therapeutic or diagnostic implications, but the initial studies are considered to be basic research. Such basic research studies must be conducted under the conditions set forth in 21 CFR 361.1(b).

All RDRC approved studies must also be approved by an IRB prior to initiation of the studies.

About the Author
Proxima CRO Team
Stephanie Mull
Director of Project Management

Stephanie has over 20 years of clinical research experience working from the site, CRO and sponsor perspectives. She graduated Summa Cum Laude from Concordia University in St. Paul, MN, with a degree in Natural Science - biology and math.

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