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U.S. Department of Health and Human Services

Drugs

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Historical Information for RDRC Program

The Radioactive Drug Research Committee (RDRC) program began when the Food and Drug Administration published a Federal Register notice on July 25, 1975 classifying all radioactive drugs as either new drugs requiring an Investigational New Drug Application (IND) for investigational use (21 CFR 312) or as generally recognized as safe and effective when administered under the conditions specified in the RDRC regulations (21 CFR 361.1).