FDA Finalizes REMS Program for ESAs,; Amgen Continues to Study Risks
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چکیده
منابع مشابه
Message to the FDA on ESAs: REMS is not enough, more studies are needed.
S ince March 24, 2010, the Food and Drug Administration (FDA) has been requiring a “Risk Evaluation and Mitigation Strategy” (REMS) for all patients who are treated with erythropoiesis-stimulating agents (ESAs) (1). Although regulatory authorities elsewhere in the world have not as yet taken this approach, experience suggests that these agencies often take their cues from the FDA. Most nephrolo...
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ژورنال
عنوان ژورنال: JNCI Journal of the National Cancer Institute
سال: 2010
ISSN: 0027-8874,1460-2105
DOI: 10.1093/jnci/djq162