A. Rulemaking/Enforcement Agencies and Committees

4. Radioactive Drug Research Committee (RDRC)

The RDRC is the administrative body responsible for the utilization of radioactive materials in human research subjects for the purpose of obtaining basic information regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic, or similar purpose or to determine the safety and effectiveness of a drug in humans. This committee serves as an in-house extension of the Food and Drug Administration (FDA), thus expediting review of protocols and eliminating the need to submit a Notice of Claimed Investigational Exemption for a New Drug (IND) form to the FDA in certain circumstances. The RDRC meets at least 4 times a year and it's responsibilities include, but are not limited to, the following:

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