Amarin settles with the FDA over off-label promotion suit; mobile apps often share medical information with third parties; drug spending rose 12% in 2014
2016 May Bring More Warning Letters, Guidance from FDA
It is worth noting that the FDA sent only nine warning letters last year, all focused on well-recognized violations, such as minimization of risk information and unsubstantiated claims.
The FDA settles with Pacira, rescinds warning letter
The FDA withdrew a 2014 warning letter related to Pacira Pharmaceuticals’ marketing of its painkiller Exparel as part of a settlement reached by both parties this week.
Industry watches Pacira’s off-label case against the FDA