FDA Week - 10/13/2017

FDA To ITC: Don't Take Up Amarin Omega-3 Complaint, Pom Doesn't Apply

October 12, 2017
FDA's top lawyers argue that the U.S. International Trade Commission should not take up a recent unfair competition case filed by Amarin Pharma asking the commission to block importation and essentially freeze U.S. inventory of certain synthetic omega-3 products being sold as dietary supplements. The lawyers note that FDA hasn't determined whether the challenged products are drugs or dietary supplements, and argue ITC would usurp FDA's legal responsibility to decide the regulatory status of products and open the door for...

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