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Biologics Working Party outlines information for quality portion of investigational applications

This article was originally published in The Gold Sheet

Executive Summary

A new guideline from the European Medicines Agency's Biologics Working Party notes that "there are clear differences between the requirements for a dossier for a clinical trial and a marketing authorization dossier. While the latter has to ensure a consistent, state-of-the-art quality of a product for widespread use in patients, information to be provided in an IMP should mainly focus on those quality attributes related to safety aspects." The deadline for public comment is Aug. 31

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