The evolving process of European combination product review, Part i
Donawa, M.E.
Medical Device Technology 19(6): 32; 34-35
2008
ISSN/ISBN: 1048-6690 PMID: 18988546 Document Number: 618999
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 discusses European requirements that apply to DES. Part II will discuss the new guideline, other stent guidelines and evolving process of drug-device regulatory review in Europe.