QUOTED. 23 May 2019. Armin Ritzhaupt.
Much-awaited draft guidance on quality expectations for EU marketing authorization applications for integral and other types of drug-device combination products is due to be published for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"The new draft guidance will contain “clear instructions” on what to submit in a dossier."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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