Drugs
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Historical Information on REMS for Extended-Release and Long-Acting Opioid Drugs
This page includes background and historical information on the risk evaluation and mitigation strategy (REMS) for extended-release (ER) and long-acting (LA) opioid drugs. For additional information, please see REMS for Extended-Release and Long-Acting Opioids.
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July 9, 2012 Approval Letters
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2011 FDA Action on REMS for ER/LA Opioids
- Federal Register Notice: Draft Blueprint for Prescriber Education for Long-Acting/Extended-Release Opioid Class-Wide REMS; Availability; Request for Comments
11/4/2011 - FDA Responses Additional Industry Questions Submitted Following the May 16, 2011 Meeting
6/17/2011 FDA Acts to Reduce Harm from Opioid Drugs
4/19/2011- Letter Sent to Opioid Manufacturers Outlining Opioid REMS Implementation (PDF - 61KB)
Appendix A: Content of Education Program (PDF - 37KB)List of Extended-Release and Long-Acting Opioid Products Required to Have an Opioid REMS Questions and Answers: FDA Requires a Risk Evaluation and Mitigation Strategy (REMS) for Long-Acting and Extended-Release Opioids
4/19/2011- Podcast and Transcript on Technical Briefing
4/20/2011
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2010 Advisory Committee Meeting
- July 22-23, 2010 Joint Meeting of the Anesthetic and Life Support Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee
- Summary Minutes for the July 22-23, 2010 meeting (PDF - 170KB)
- Transcript for the July 22, 2010 meeting (PDF - 934KB)
- Transcript for the July 23, 2010 meeting (PDF - 869KB)
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Meetings with Industry and Stakeholders
FDA Opioid REMS Meeting with Industry, May 16, 2011 December 4, 2009 FDA/Industry Working Group (IWG) Public Meeting on Risk Evaluation and Mitigation Strategies (REMS) for Certain Opioids May 27-28, 2009 Public Meeting on Risk Evaluation and Mitigation Strategies for Certain Opioids May 4-5, 2009 Stakeholders Meeting on Opioid Analgesic and Risk Evaluation and Mitigation Strategies (REMS) March 3, 2009 Industry Meeting on Risk Evaluation and Mitigation Strategy (REMS) for Certain Opioid Drugs February 10, 2009 Stakeholders Meeting: Information and Presentations
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