I will watch the hearing. I intend to comment specifically RE my efforts to correct a perceived wrong. This will include the censorship of Amarin CP comments. IMO it's also highly relevant to weave in the ANCHOR rescission. Without the rescission and ANCHOR CRL there would be no Amarin v. FDA.
I'm also pushing the FDA Science Board Advisory Committee to hold a hearing r/t 10.75 c 3 requests.
Additionally I'm patiently waiting for the Commissioners Office to see eye to eye when it comes to reviewing my 10.75 c 3...(FDA Science Board Ad Com is now involved).
If you hear any inside scoop on the DOJ RE TEVA (and can share the info), please contact me.
I'm going to drop my FTC contact an email next week, the FTC & DOJ should have had better communications RE TEVA Watson merger.
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
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