Big business has used similar tactics in cases related to productlabeling, pharmaceutical sales and securities disclosures, with mixed success.
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Rare coughing reactions have been well-described in the European productlabeling of Nebido, Indevus CEO Cooper said in a statement.
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Issues related to differential assessment, productlabeling and utilization, staff education, and cost of care are the primary focus of this article.
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The authors say their findings highlight the urgency for improved regulation, as well as widespread use of supply-chain certification and consumer productlabeling.
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CONTACT: Minh Doan, 301-827-7001 The committee will discuss updating susceptibility test information in systemic antibacterial drug productlabeling.
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The company said it was in discussions with the FDA to address the agency's outstanding questions and finalize the productlabeling as soon as possible.
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The makers said communicating safety concerns through productlabeling and education "will minimize risk as the necessary data are acquired" from new and ongoing studies.