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 evolving process of drug-device regulatory review in Europe.
Donawa
Maria E
ME
Donawa Consulting, Rome, Italy. medonawa@donawa.com
D001807:Blood Vessel Prosthesis; D018795:Device Approval / Q000592:standards*; D004343:Drug Implants / Q000592:standards*; D005060:Europe; D017408:Guidelines as Topic; D015607:Stents / Q000592:standards*
D004343:Drug Implants