Radioactive Drug Research Committee

An investigator formally submits a research protocol to the RDRC with detailed description of the study, but prior to submission, the protocol must be approved by the Institutional Review Board. The RDRC meets at least quarterly if active research is pursued, with at least 50% membership present. Members with conflict of interest in a protocol must excuse themselves from voting on the protocol. Based on the critical review of the protocol, the study may be or may not be approved by the RDRC. If approved, the study will be regularly monitored on the progress. Any adverse effects encountered during the study must be immediately reported to the FDA. The Chairman of the RDRC is the primary contact person with FDA and must submit an annual report on all projects. Also any change in the membership must be reported to and approved by the FDA. 

---

Radioactive Drug Research Committee Rising-Dose Tolerance Request for Approval Reduction In Force... 

New radiopharmaceuticals are reviewed by Radioactive Drug Research Committees at universities or research laboratories. In 2003, there were 284 such research studies in the United States involving 2,797 human subjects and >120 different radioactive molecules. Efforts are being made to simplify toxicity studies. Radiotracers are often radio-labeled natural body constituents, administered in micromolar or millimolar quantities, far less than one hundredth of the toxic dose. 

---