The US FDA's Office of Prescription Drug Promotion (OPDP) has taken Collegium Pharmaceutical Inc. to the woodshed in the office's first untitled letter and tangible enforcement action of 2018, which says the warning information for Xtampza ER (oxycodone extended-release) were visibly obstructed by a table and chair at an exhibit booth.
Xtampza ER Warnings Can't Be Hidden Behind Table And Chairs, US FDA Tells Collegium
OPDP's first enforcement letter of 2018 is notable because it comes much earlier than 2017's first, cites an opioid, and signals that the US FDA is monitoring medical meetings.
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