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US FDA issues guidelines on imaging agents

This article was originally published in Clinica

Executive Summary

Manufacturers of contrast agents and radiopharmaceuticals used in medical imaging have three final guidances from the US FDA on how they should structure clinical trials and prepare premarket submissions. The three guidance notes cover such issues as conducting safety assessments, tailoring clinical trials so they focus on the agent's performance in diagnosing and monitoring specific diseases and conditions, the selection of trial subjects and the analysis of clinical trial data.

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