Drugs

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.

 

Page Last Updated: 02/23/2017
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