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Oncologic Drugs Advisory Committee
May 10, 2007
The statements contained in this document(s) are those of the product's sponsor, not FDA, and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Amgen, Inc. Briefing Material: Safety of Erythropoiesis-Stimulating Agents (ESAs) in Oncology (pdf)
Supplement to Amgen, Inc. Briefing Material (pdf)
Portions of this document have been determined to be exempt from disclosure under the Freedom of Information Act (the FOIA) (5 U.S.C. § 552). These redacted portions will appear as white space on the screen or on the printed page.
FDA Briefing Material: Continuing Reassessment of the Risks of Erythropoiesis-Stimulating Agents (ESAs) Administered for the Treatment of Anemia associated with Cancer Chemotherapy (pdf)
Errata for FDA Briefing Material (htm)