FDA Opioid Action Plan
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
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