Draft Guidance for Industry on Coronary Drug Eluting Stents-Nonclinical and Clinical Studies; Availability

Zusammenfassung

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Coronary Drug Eluting Stents--Nonclinical and Clinical Studies." This draft guidance is intended to provide recommendations to sponsors or applicants planning to develop, or to submit to FDA, a marketing application for a coronary drug eluting stent (DES). The draft guidance discusses the clinical studies that should be performed and the data that should be submitted to support such an application. The draft guidance is being issued in two parts. The companion document provides additional and more detailed guidance on some of the recommendations included in this document. The companion document is intended to be used together with this draft guidance.