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Mipomersen REMS Would Rely on Education, Not Prescribing Restrictions, To Address Hepatotoxicity

This article was originally published in The Pink Sheet Daily

Executive Summary

REMS will include a prescription form that has prescribers attest that the prescription is medically appropriate and that they will monitor hepatotoxicity biomarkers, according to FDA and Genzyme briefing materials for an Oct. 18 Metabolic and Endocrinologic Drugs Advisory Committee.


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