Fentanyl REMS May Need Better Surveillance Methods Before Possible Modifications
Executive Summary
Sponsors currently use sources such as spontaneous adverse event reports to assess whether REMS for immediate-release fentanyl products is achieving its purpose, although such methods are limited in their ability to portray a clear picture.
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Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.
Recent And Upcoming FDA Advisory Committee Meetings
Recent and upcoming US FDA advisory committee meetings and a summary of topics covered.