Opioids and FDA Opioid Action Plan

To address  growing epidemic of opioid abuse, dependence and overdose in the US

  • Expand use of advisory committees
  • Develop warnings and safety information for immediate-release (IR) opioid labeling
  • Strengthen postmarket requirements
  • Update Risk Evaluation and Mitigation Strategy (REMS) Program
  • Expand access to abuse-deterrent formulations (ADFs) to discourage abuse
  • Support better treatment.
  • Reassess the risk-benefit approval framework for opioid use


Image credit: FDA

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