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Continued Regulatory Actions Affecting the Use of Erythropoiesis-Stimulating Agents

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On July 30, 2008, the US Food and Drug Administration (FDA) sent a Complete Response and Safety Labeling Change Order to the sponsors of erythropoiesis-stimulating agents (ESAs), ordering changes to the ESA package inserts, referred to as labels. The FDA had been in discussions with the sponsors since April regarding changes to the ESA labels, but the two parties were unable to agree about certain specific wording. Consequently, the FDA invoked for the first time its authority under section 505(o)(4)(E) of the 2007 Food, Drug, and Cosmetic Act to order a sponsor to make revisions to a product label. These . . . [Click for More]