The FDA requires investigators to submit an IND for radioactive drugs, biologics, "cold" kits to be used for radiolabeling, and radionuclide generators that are to be used for investigational purposes, including testing of their safety and efficiency. An IND may not be required for certain research designed to study basic biochemistry, physiology, pathophysiology or metabolism if the use is reviewed and approved by the Radioactive Drug Research Committee. To this end, the FDA regulations permit the establishment of a RDRC, which has the authority to review and approve research involving the administration of unapproved radiopharmaceuticals intended to solely obtain information about the human physiology, pathophysiology, biochemistry or metabolism of the drug. The RDRC review and approval of such studies is in lieu of obtaining a FDA review and approval of an investigational new drug (IND) application.
The RDRC and the JRSC have members in common and meet simultaneously and use the same set of forms for investigators. Please contact the RDRC/JRSC at Ext. 5-5660, for additional information regarding their application and review requirements for research involving radiation, radiation dosimetry, the significance of the dose or radioactive drugs.