Amarin Corp Plc (AMRN)

[north40000]

Manufacturer Communications Regarding Unapproved Uses of
Approved or Cleared Medical Products
Part 15 Public Hearing, November 9-10, 2016
DRAFT VERSION 10.31.2016 – Please note this agenda is subject to change
Electronic or written comments will be accepted after the public meeting until January 9, 2017. Submit
electronic comments to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville MD
20852. All comments must be identified with docket number FDA-2016-N-1149. For additional
information, please see the Notification of Public Hearing that published in the Federal Register (81 FR
60299, September 1, 2016).
Additional information related to this public meeting is available on the FDA web site at