Risk Evaluation and Mitigation Strategies (REMS) and Opioid Analgesics Webinar

The Center for Drug Evaluation and Research (CDER) and Office of Special Health Issues (OSHI) developed the following Webinar to better inform stakeholders about general issues related to Risk Evaluation and Mitigation Strategies (REMS) and specific issues related to REMS for certain opioid analgesics. 

Part I –Introduction (8:21 minutes)
Douglas C. Throckmorton, M.D.
Deputy Director (CDER)
https://webmeeting.nih.gov/p53364025/
 

Part II – Opioid Analgesics (6:28 minutes)
Sharon Hertz, M.D., Deputy Division Director                                
Division of Anesthesia, Analgesia, and Rheumatology Products (CDER)
https://webmeeting.nih.gov/p59178873/

Part III – REMS (23:51 minutes)
John Jenkins, M.D.  
Director, Office of New Drugs (CDER)
https://webmeeting.nih.gov/p51598115/

Part IV – Next Steps (6:22 minutes)
John Jenkins, M.D.  
Director, Office of New Drugs (CDER)
https://webmeeting.nih.gov/p57998755/

PDF Version of Slides

• Part I - Introduction (PDF - 53KB)
• Part II - Opioid Analgesics (PDF - 68KB)
• Part III - REMS (PDF - 310KB)
• Part IV - Next Steps (PDF - 61KB)

Related Information

• Opioid Drugs and Risk Evaluation and Mitigation Strategies (REMS)