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 – Exploring the Path Forward
• Industry Meeting on Modifying ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) – 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 Announcement

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 Analgesics (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

Resources

• Opioid Analgesic REMS