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TNF Blocker Fungal Infection: FDA Uses REMS For Relabeling, Education

Executive Summary

FDA is using its new drug safety authority to require label changes within 30 days for all four products in the tumor necrosis factor inhibitor class

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FDA's release of Centocor from a Risk Evaluation and Mitigation Strategy for Simponi could signal a reprieve from the REMS regulatory burden for other tumor necrosis factor inhibitors as well.

Centocor's Simponi Becomes First TNF Blocker To Escape REMS Duties

FDA's release of Centocor from a Risk Evaluation and Mitigation Strategy for Simponi could signal a reprieve from the REMS regulatory burden for other tumor necrosis factor inhibitors as well.

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