FDA Exploring Partnerships As Alternative To REMS Mandate For Opioid Education

 
• By Michael McCaughan
  
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The US FDA is continuing to think through mechanisms to make opioid prescriber education mandatory – either separate from or in addition to relying on its REMS authority. 

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Third party partnerships could help the FDA make opioid prescriber education mandatory. • Source: Alamy

The US Food and Drug Administration is exploring partnerships with other federal agencies and private stakeholders as a potential approach to implementing mandatory prescriber training for opioids without relying on its relatively blunt risk evaluation and mitigation strategy (REMS) authority, Center for Drug Evaluation and Research Director Patrizia Cavazzoni said during an 4-5 April opioid prescriber education meeting.

“Through our recent conversations with stakeholders, we have discussed alternative collaborative approaches, such as partnering with our federal colleagues, medical...

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