On Tuesday, September 11, 2007, the U.S. Food and Drug Administration (FDA) held a joint meeting of the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) and the Drug Safety and Risk Management Committee. At this meeting, Amgen presented data on the safety and efficacy of erythropoiesis-stimulating agents (ESAs) in chronic renal failure.

Below are links to the briefing material Amgen has submitted to CRDAC and to the FDA for public disclosure on the FDA’s website and to the slide presentation that Amgen is presenting at the CRDAC meeting. A link to the FDA Dockets Management page including the FDA briefing material is also provided.