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