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Cymbalta Pregnancy Risk Fit FDA's New Power To Mandate Post-Market Study

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA's application of its new ability to require - as opposed to request - post-marketing studies under the FDA Amendments Act is on display in the review of a fibromyalgia claim for Lilly's Cymbalta (duloxetine)

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Chart: Current Class Of Risk Evaluation & Mitigation Strategires

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