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Opana ER Panel Urged To Disregard ‘Invalid’ Human Abuse Liability Study

Executive Summary

In unusual public hearing, Edwin Thompson, head of the US firm that contract manufactures Endo’s long-acting opioid, tells US FDA advisory committee that intranasal ‘liking’ study violated FDA requirements. Thompson has petitioned the agency to do away with need for human abuse liability studies entirely, asserting they are inherently flawed.

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