U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Information by Drug Class
  5. Industry Meeting on Modifying ER/LA Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) – January 25, 2017
  1. Information by Drug Class

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.

 

Related Information

Back to Top