The evolving process of European combination product review, Part II.
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.
Donawa
Maria E
ME
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D054855:Drug-Eluting Stents / Q000592:standards*; D005062:European Union; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards* / Q000639:trends*