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FDA issues imaging drug guidance

This article was originally published in The Gray Sheet

Executive Summary

Recommendations on assessing imaging agent safety, designing clinical development programs and tailoring them to reflect the use of the agents are outlined in guidance titled "Developing Medical Imaging Drug and Biological Products," which addresses contrast agents and diagnostic radiopharmaceuticals in various imaging modalities, including CT, MRI, SPECT and PET. The guidance originally was released in 1998 as a single draft document to address in vivo radiopharmaceuticals for diagnostic and monitoring use (1"The Gray Sheet" May 24, 1999, p. 9). In 2003, the draft was divided into three sections to make it more user-friendly...
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