Single Shared System

REMS Experience Counts

We’ve heard from pharmaceutical manufacturer sponsors that the thought of having the FDA mandate a Single Shared System REMS on their product gives them nightmares.   Well, we’re here to tell you, there’s no need to lose sleep. 

In 2010, the FDA initiated a Single Shared System REMS for certain drug classes that involve multiple products by multiple manufacturers.  And, since that time, UBC has been a part of every Single Shared System REMS program. 

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