1. Pink Sheet
  2. >>Drug Safety

US FDA Advisory Panel Split On Value Of Education In Fentanyl REMS

 
• By Michael Cipriano

Some members feel more education has important role in risk management for transmucosal immediate-release fentanyl products, while others think further education will be useless in ensuring the REMS meets its goals. 

Members of the US FDA's Drug Safety and Risk Management Advisory Committee and Anesthetic and Analgesic Drug Products Advisory Committee generally agreed that the goals of the risk evaluation and mitigation strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) products are appropriate, but panelists were split on the value of more education to improving its performance

In a wide-ranging discussion on a series of topics related to the TIRF REMS at an Aug. 3 joint advisory...

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 Drug Safety

More from Pink Sheet

Semaglutide: EMA Safety Probe Confirms Rare Eye Disorder Risk

 
• By Neena Brizmohun

The EU product information for Novo Nordisk’s semaglutide medicines is to be updated to include non-arteritic anterior ischemic optic neuropathy as a side effect with a frequency of “very rare.”

Infographic: Leqembi – A Geographical Comparison

 
• By Anabel Costa-Ferreira

The Pink Sheet explores how regulatory approvals for Leqembi differ around the world, and looks at what is coming next.

EU Pharma Reform: Council Proposal A ‘Step In The Right Direction’ But ‘More Work To Be Done’

 
• By Eliza Slawther

Experts from EUCOPE explain why the Council of the EU’s position on the proposed overhaul of the general pharmaceutical legislation could offer more predictability for companies than the commission’s initial offering.