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Wenn sie in die Kategorie der schwerwiegenden unerwnschten Ereignisse fallen, mssen sie den Behrden der Lnder, in denen die Studie stattfindet, gemeldet werden (MDR und Leitfaden MDCG 2020-10/1 "Safety reporting in clinical examinations of medical devices under the Regulation (EU) 2017/745")

Other commenters supported CMS's decision to introduce the measure through voluntary reporting

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Pharmacokinetic data half-life, bioavailability by route, and clearance pathways varies widely across peptides and is essential context for any new design