title: Drug eluting stents and the critical path initiative: Evolving paradigms for safety evaluation.
abstract: Recent discussions between FDA and other stakeholders have focused on the benefits and risks associated with drug eluting stents (DES). A particular topic of focus is DES thrombosis, a rare, but serious, clinical event that may occur months to years after the initial implantation. FDA continues vigilant postmarket surveillance of DES currently on the market and is working with stent manufactures to ensure that new DES platforms in the development pipeline are safe and effective. FDA is also taking steps, under its Critical Path Initiative (CPI) [FDA. Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, March 2004.http://www.fda.gov/oc/initiatives/criticalpath/whitepaper.html], to help address current and future DES safety issues. This article describes some of these activities.:
authors: Office of the Commissioner, Food and Drug Administration (FDA), Rockville, MD, USA. Electronic address:wendy.sanhai@oc.fda.gov.
authors: Wendy R
authors: WR
authors: Sanhai
authors: Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, FDA, Rockville, MD, USA.
authors: Norman
authors: N
authors: Stockbridge
authors: Division of Cardiovascular Devices, Center for Devices and Radiological Health, FDA, Rockville, MD, USA.
authors: Robert P
authors: RP
authors: Fiorentino
authors: Division of Cardiovascular Devices, Center for Devices and Radiological Health, FDA, Rockville, MD, USA.
authors: Takahiro
authors: T
authors: Uchida
authors: FDA, Rockville, MD, USA.
authors: Kathleen
authors: K
authors: Uhl
authors: Duke University Medical Center, Cardiovascular Devices Unit, Duke Clinical Research Institute, Durham, NC 27710, USA. Electronic address:kruco001@mc.duke.edu.
authors: Mitch W
authors: MW
authors: Krucoff