The evolving process of European combination product review, Part Ii
Donawa, M.E.
Medical Device Technology 19(7): 26; 28-31
2008
ISSN/ISBN: 1048-6690 PMID: 19133625 Document Number: 627776
A new European guideline on drug-eluting stents (DES) introduces for the first time detailed information that European drug authorities should review concerning the medicinal substance that is incorporated into this type of drug-device combination product. Part I of this article discussed European requirements that apply to DES. This article discusses the new guideline, other stent guidelines, and the evolving process of drug-device regulatory review in Europe.