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Radiopharmaceutical Indications Need Not Be Disease-Specific - Final Rule

This article was originally published in The Gray Sheet

Executive Summary

FDA's final rule on "Regulations for In Vivo Radiopharmaceuticals Used for Diagnosis and Monitoring," allows sponsors to propose indications that refer to a "biochemical, physiological, anatomical, or pathological process or to more than one disease or condition" in cases where the radiopharmaceutical "is not intended to provide disease-specific information."

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