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Neuromed's Extended Release Hydromorphone Gets Committee Review

This article was originally published in The Pink Sheet Daily

Executive Summary

Exalgo will be another test of FDA's willingness to approve opioids in the absence of a class-wide REMS.

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Onsolis' REMS Is Not Template For Long-Acting Opiates - FDA

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Opioids Pending At FDA Held Up By Anti-Abuse Claims, Not REMS Planning

Opioid products awaiting FDA approval are not being put on hold for completion of a Risk Evaluation and Mitigation Strategy, said Office of New Drugs Director John Jenkins

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