Risk Management Plans Are In Fact A “Big Deal,” FDA Tells Gilead
Executive Summary
FDA's citation of Gilead for downplaying the risk management plan for its pulmonary arterial hypertension product Letairis (ambrisentan) is noteworthy for what it doesn't cite as much for what it does
You may also be interested in...
Gilead's Letairis Gets Boost Against Actelion's Tracleer With Removal Of Liver Warning
REMS helps drive the endothelin receptor antagonist to a cleaner label, as the pulmonary arterial hypertension drug's black box will be modified and liver testing requirements dropped.
Gilead's Letairis Gets Boost Against Actelion's Tracleer With Removal Of Liver Warning
REMS helps drive the endothelin receptor antagonist to a cleaner label, as the pulmonary arterial hypertension drug's black box will be modified and liver testing requirements dropped.
Four Ways To Draw DDMAC's Ire: In Print, On A Dosing Card, In A Script, And In Person
In a series of letters, FDA cites Lilly, Cephalon, Bayer and Amylin for promotional violations.