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Regulators Find Room For ICH Q3D Metal Impurity Risk Assessments To Improve

FDA Says Submissions Rarely Rejected Due to Poor Quality Risk Assessments

Executive Summary

The pharmaceutical industry is doing a better job of conducting the risk assessments called for in the ICH Q3D elemental impurity limits guideline, and regulators are not rejecting applications because of poor quality assessments, yet regulators say there is still room for improvement.

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