RADIOACTIVE DRUG RESEARCH COMMITTEE
The Radioactive Drug Research Committee (RDRC) is a subcommittee of the U-M's Radiation Policy Committee. The RDRC reviews certain research protocols involving radiopharmaceuticals as required by Food and Drug Administration (FDA) regulations (21 CFR 361.1).
The RDRC research pathway involves the oversight of basic human research for the purpose of advancing scientific knowledge. The research is intended to obtain basic information regarding the metabolism of radioactive drugs including kinetics, distribution, dosimetry, and localization or obtain basic information regarding human physiology, pathophysiology, and biochemistry of radioactive drugs. Only basic research studies are permitted under 21 CFR 361.1.
Research conducted under the RDRC approval process is NOT intended for the immediate therapeutic, diagnostic, pr preventive benefit to the human research subject involved. In addition, RDRC research is NOT intended to determine the safety and effectiveness of a radioactive drug in human research subjects as a therapy, diagnostic, preventive medical product.
The RDRC reviews human research protocols involving radioactive drugs without: (1) a New Drug Application (NDA) filed with the FDA, (2) an approved Investigational New Drug (IND) application, or (3) an IND Exemption may be subject to review by the RDRC in compliance with 21 CFR 361.1.
SUBCOMMITTEE ON THE HUMAN USE OF RADIOISOTOPES
The Subcommittee on the Human Use of Radioisotopes (SHUR) is a subcommittee of the U-M's Radiation Policy Committee and is comprised of the identical membership as the RDRC. The SHUR is responsible for the review and approval of applications for the clinical use of radioactive materials in or on humans submitted by medical authorized users and the review of human research subject protocols involving the administration of radiopharmaceuticals to research subjects that are not covered under 21 CFR 361.1.
The SHUR reviews studies involving FDA-approved New Drug Applications (NDA), Investigational New Drugs (IND), and IND Exemptions and the clinical administration of radiopharmaceuticals intended for the therapeutic us, diagnostic use, or similar purposes or to determine the safety and effectiveness of a drug (clinical trials).
RDRC/SHUR applications involving the human use of radioisotopes for research are primarily covered by Section 21 ('Ionizing Radiation') of the eResearch application.
This webpage was generated in an effort to provide assistance in completing the application within the new eResearch system. It should be considered a work in progress.