The evolving process of European combination product review, Part II.
نویسنده
چکیده
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.
منابع مشابه
The evolving process of European combination product review, Part I.
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...
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ورودعنوان ژورنال:
- Medical device technology
دوره 19 7 شماره
صفحات -
تاریخ انتشار 2008