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  1. Drug Safety and Availability

Historical Information on REMS for Opioid Analgesics

This page includes background and historical information on the Risk Evaluation and Mitigation Strategy (REMS) for extended-release (ER), long-acting (LA), and immediate-release (IR) opioid drugs. For additional information, please see Opioid Analgesic REMS.

2017 FDA Actions on REMS for Opioid Analgesics

2016 FDA Actions

2012 FDA Actions on REMS for ER/LA Opioids

2011 FDA Action on REMS for ER/LA Opioids

2010 Advisory Committee Meeting

Meetings with Industry and Stakeholders

Background Information

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