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
- May 3-4, 2016: Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee Meeting AnnouncementExternal Link Disclaimer
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
For older achived links please visit: Information by Drug Class > Historical Information on REMS for Opioid AnalgesicsExternal Link Disclaimer (archive-it.org)
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