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FDA’s Promotional Enforcement Still Playing It Safe

 
• By Brenda Sandburg

Even with letter citing Spanish video for Oxtellar seizure, US regulatory agency likely to issue record low number of letters this year.

Supernus Pharmaceuticals Inc. is the fifth company to get cited by FDA this year for a misleading drug promotion, and while the criticism is typical the context is somewhat unusual.

The agency’s Office of Prescription and Promotion (OPDP) objected to a Key Opinion Leader Spanish video for Supernus’ seizure drug Oxtellar XR (oxcarbazepine). In an Oct. 31

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US FDA Retirements Continue Unabated With Drug Inspectorate Leaders, Former Chief Counsel

 
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