FDA's Rx Promotion Citation Drought Continued In 2015
This article was originally published in The Pink Sheet Daily
First Amendment litigation and guidance document work may be factors behind decline.
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Office of Prescription Drug Promotion seemed to expand its focus in issuing 11 letters last year.
Even with letter citing Spanish video for Oxtellar seizure, US regulatory agency likely to issue record low number of letters this year.
FDA is having trouble meeting its internal goal of 45-day reviews for core launch materials due to complex issues that have required medical review division consultations, Office of Prescription Drug Promotion Director Abrams says.