U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Information by Drug Class
  5. Historical Information on REMS for Opioid Analgesics
  1. Information by Drug Class

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

For older achived links please go to: Information by Drug Class > Historical Information on REMS for Opioid Analgesics (archive-it.org)

2011 FDA Action on REMS for ER/LA Opioids

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

ResourcesForYou

 
Back to Top