1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Review Pathways

New Opioid Approval Standard Intended To Drive Development Into Other Therapeutics

 
• By Derrick Gingery

US FDA explored whether existing law allowed for the higher standard, but determined new authority granted by Congress was necessary.

opioid pills and syringes
The FDA wants Congress to give it authority to set a higher bar for opioid approval. • Source: Shutterstock

The US Food and Drug Administration is hoping its proposed new opioid approval standard will alter the course of pain therapeutic development.

The FDA’s Overdose Prevention Framework includes exploration of changes to opioid approval standards so new products are judged on whether they are safer than those already on the market

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Review Pathways

More from Pathways & Standards