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Sie suchen in allen Bereichen nach dem Autor Kneuß T.
In der Rubrik Zeitschriften haben wir 1 Beitrag für Sie gefunden
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MerkenDrug-Device Combination Products
Rubrik: Gesetz und Recht
(Treffer aus pharmind, Nr. 04, Seite 533 (2019))
Drug-Device Combination Products / An Overview · Kneuß T · Bayer AG, Berlin
Almost half of the top 20 drugs incorporate a drug constituent with at least one device constituent. The device constituent parts are typically used for drug preparation/reconstitution or drug delivery. Products combining drugs with devices are called Combination Products, as they combine two or more types of regulated product. The term “Combination Product” is common in the industry, even though it is currently defined only in a few jurisdictions. The most comprehensive definition can be found in the Code of Federal Regulations (CFR) Title 21 (Part 3.2.). This definition states that Combination Products include four types of product, which always require that ...
