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Because of a lapse in government funding, the information on this website may not be up to date, transactions submitted via the website may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. The NIH Clinical Center (the research hospital of NIH) is open. For more details about its operating status, please visit cc.nih.gov. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Duties of the RDRC

​The Radioactive Drug Research Committee (RDRC) reviews and approves the use of radioactive drugs for research purposes in humans for which an approved NDA (New Drug Application) or an approved INDA (Investigational New Drug Application) does not exist.  ​​

​​​Approvals​

Approval of proposed research may be granted when the RDRC has determined, in accord with the standards set forth in 21 CFR 361.1, that: 

  • The pharmacological dose is within the limits set forth in the standard. 

  • The radiation dose from the radioactive drug and other x-ray or radiation procedures that are part of the research study is within the limits set forth in the standard. 

  • The radiation exposure is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain. 

  • The study meets the other requirements set forth in the standard regarding qualifications of the investigator, proper authorization for handling radioactive materials, selection and consent of research subjects, quality of radioactive drugs used, research protocol design, reporting of adverse reactions, and approval by an appropriate Institutional Review Board (IRB). ​

The RDRC meets at least once each quarter in which research activity has been authorized or conducted to review committee activities. ​

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