Zdrowie i gospodarka · 24.04.2008
Draft Guidance for Industry on Developing Coronary Drug Eluting Stents; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop entitled "Coronary Drug-Eluting Stent (DES) Guidance Document Workshop." FDA is cosponsoring the workshop with the Advanced Medical Technology Association (AdvaMed). The purpose of the workshop is to discuss the draft guidance entitled "Coronary Drug-Eluting Stents: Nonclinical and Clinical Studies" announced in the Federal Register of March 27, 2008, and its companion document entitled "Coronary Drug- Eluting Stents-Nonclinical and Clinical Studies (Companion Document)" (the Companion Document). The workshop intends to solicit additional comments on the issues and questions presented in the draft guidance during the open comment period.