December 4, 2009 FDA/Industry Working Group (IWG) Public Meeting on Risk Evaluation and Mitigation Strategies (REMS) for Certain Opioids
On December 4, 2009, FDA held a public meeting with sponsors of certain opioid drug products regarding the opioid REMS. FDA has encouraged affected sponsors to work collectively to develop a proposed REMS. The purpose of this meeting was to hear from sponsors about the status of the development of a proposed REMS and their views regarding the specific features of the REMS.
- Meeting Agenda (PDF - 17KB)
- Presentations (PDF - 599KB)
- Meeting Transcript (PDF - 388KB)
- View the recorded version of this meeting
Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioids
Main page for Opioid Drugs and REMS information