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BioPharmaceutical

FDA Moving Toward PAT Standardized Nomenclature And Definitions

This article was originally published in The Pink Sheet Daily

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Executive Summary

The process analytical technology component of FDA's drug quality initiative will be assisted by an independent standards-making effort and agency encouragement of comparability protocols. Part 11 and dispute resolution are other quality initiative components drawing industry input.
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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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