Industry Meeting on Modifying ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) – January 25, 2017

Part of the FDA’s Opioid Action plan is to update the REMS requirements for opioids after considering advisory committee recommendations and reviewing existing requirements. The FDA invited all affected sponsors to a meeting on January 25, 2017, to inform them of the Agency’s intention to require a REMS for immediate-release (IR), extended-release (ER), and long-acting (LA) opioid analgesics to ensure the benefits outweigh the risks of misuse, abuse, addiction, overdose, and death.

• Meeting Invitation Template (PDF - 36KB)
• Agenda (PDF - 300KB)
• Meeting Minutes (PDF - 473KB)
• Presentations
  • Development of the 2012 ER/LA Opioid Analgesic REMS – Terry Toigo, RPh, MB (PDF - 1.18MB)
  • Advice from Joint Advisory Committee Meeting May 3-4, 2016 – Doris Auth, PharmD (PDF - 387KB)
  • FDA Plan: Opioid Analgesic Education – Sharon Hertz, MD (PDF - 269KB)
  • Development of Shared System REMS – Elaine Lippmann, JD (PDF - 258KB)
  • ER/LA Opioid Analgesic REMS Overview – REMS Program Companies (RPC) (PDF - 609KB)

 

Related Information

• Risk Evaluation and Mitigation Strategy (REMS) for Extended-Release and Long-Acting Opioid Analgesics
• Opioid Medications
• FDA Opioids Action Plan
• Joint Meeting of the Drug Safety and Risk Management Advisory Committee and the Anesthetic and Analgesic Drug Products Advisory Committee