Opioid Approval Standards Could Change Under New US FDA Plan

The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.

opioids in bottles
The framework also includes supporting development of non-addictive pain treatments. • Source: Shutterstock

Authority potentially curbing new opioid approvals may become part of the US Food and Drug Administration’s effort to fight the ongoing epidemic.

A new

Four Priorities Of The FDA Overdose Prevention Framework
  • Supporting primary prevention by eliminating unnecessary initial prescription drug exposure and inappropriate prolonged prescribing

  • Encouraging harm reduction through innovation and education

  • Advancing development of evidence-based treatments for substance use disorders

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