Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III) (English, HTML)

Quality Overall Summary - Chemical Entities Clinical Trial Applications Phase III (QOS-CE (CTA - Phase III): English HTML file. From Health Canada, updated Jun 2021. View metadata, licence and the direct download on CanQuery.

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HTML

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Publisher-reported update

2021-06-02

To assist submission sponsors in preparing Clinical Trial Applications (CTAs) filed with Health Canada by outlining the Quality (chemistry and manufacturing) technical requirements for CTAs pursuant to Division C.05 of the Food and Drug Regulations.

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