John Manthei

John Manthei

Latham & Watkins LLP

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Amarin Settles Off-Label Promotion Case Against the FDA

The Amarin settlement represents another important development in the FDA’s enforcement of off-label promotion. On March 8, 2016, US District Court Judge Paul A. Engelmayer entered a Stipulation & Order of Settlement in...more

3/14/2016  /  Amarin , Caronia , First Amendment , Food and Drug Administration (FDA) , Misbranding , Off-Label Promotion , Pharmaceutical Industry , Preliminary Injunctions , Settlement

Lessons from Latham & Watkins’ Representation of Pacira Pharmaceuticals In Ground-Breaking Settlement with FDA

FDA rescinds warning letter and admits to incorrect interpretation of drug’s labelling. What can the life sciences industry learn? On December 15, 2015, Pacira Pharmaceuticals, Inc. (Pacira) announced that the US Food &...more

1/6/2016  /  Administrative Procedure Act , FDA Warning Letters , Fifth Amendment , First Amendment , Food and Drug Administration (FDA) , Life Sciences , Off-Label Promotion
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