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Subsys Makes A Bad Impression On FDA REMS Panel Members

 
• By Ramsey Baghdadi

CMS and FDA data showed prescriptions jumping while other fentanyl products were coming down.

FDA’s advisory committee review of the transmucosal immediate release fentanyl (TIRF) risk evaluation and mitigation strategy was a mixed bag of observations, recommendations, and opinions, but one thing was clear: Subsys made a bad impression on the panel.

The TIRF REMS has been viewed as a model of how other class-wide or shared REMS could work. The tone of this meeting was very different. It featured varying opinions...

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