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Quoted Combination Products Quality

QUOTED. 23 May 2019. Armin Ritzhaupt.

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Executive Summary

Much-awaited draft guidance on quality expectations for EU marketing authorization applications for integral and other types of drug-device combination products is due to be published for public consultation shortly. See what the European Medicines Agency's Armin Ritzhaupt said about it here:

"The new draft guidance will contain “clear instructions” on what to submit in a dossier." –Armin Ritzhaupt, European Medicines Agency

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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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