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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...

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