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
- FDA Takes Important Steps to Stem the Tide of Opioid Misuse and Abuse
- ANDA ER-LA REMS Mod Notif Template
- ANDA IR REMS Notif Template.docx
- NDA ER-LA REMS Mod Notif Template
- NDA IR REMS Notif Template
- FDA Education Blueprint for Health Care Providers Involved in the Management or Support of Patients with Pain
- Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics â Exploring the Path Forward
- Industry Meeting on Modifying ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) â January 25, 2017
2016 FDA Actions
2012 FDA Actions on REMS for ER/LA Opioids
- FDA introduces new safety measures for extended-release and long-acting opioid medications
- Avinza approval letter
- Butrans approval letter
- Dolophine approval letter
- Duragesic approval letter
- Embeda approval letter
- Exalgo approval letter
- Kadian approval letter
- MS Contin approval letter
- Nucynta ER approval letter
- Opana ER approval letter
- Opana ER approval letter
- Oxycontin approval letter
- Oxycontin approval letter
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
- FDA Responses Additional Industry Questions Submitted Following the May 16, 2011 Meeting
- FDA Acts to Reduce Harm from Opioid Drugs
- Letter Sent to Opioid Manufacturers Outlining Opioid REMS Implementation
- Appendix A: Content of Education Program
- List of Long-Acting and Extended-Release 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
- Podcast and Transcript on Technical Briefing
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
- Transcript for the July 22, 2010 meeting
- Transcript for the July 23, 2010 meeting
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
Background Information
- Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS): November 2009 Update
- Background on Extended-Release and Long-Acting Opioid REMS (2009)
- Opioid Drug Approvals (2009)
- REMS and Opioid Analgesics Webinar