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Alias Born | 01/12/2013 |
Friday, January 23, 2015 3:43:20 PM
It's been a full year since CDER rescinded Anchor SPA. I have no doubt if any Big Pharna owned Amarin, at the time of the October 16th Ad Com, CDER would have followed proper Regulation and Guidance related to Special Assessment Protochols. I support this petitions requests to reinstate Anchor SPA.
I also would like to bring to the attention of Amarin stakeholders, the FDA can be held accountable under Federal Torts Claim Act 28 CFR 14.
Date damaged: 10-29-2013 through current date SPA Rescindment
Supported information: Amarin 8-K dated 10-29-2013
http://investor.amarincorp.com/secfiling.cfm?filingID=1193125-13-416032&CIK=897448
The First Amendment prohibits the making of any law abridging the freedom of speech, infringing on the freedom of the press, interfering with the right to peaceably assemble or prohibiting the petitioning for a governmental redress of grievances.
Dockets Management has violated Title 18 USC Section 241
Censored Citizen Petition Comments Docket FDA-2013-P-1612 Request the Agency to Overturn the Decision to Rescind the Special Protocol Assessment for VASCEPA and to Delay the PDUFA Date for ANCHOR sNDA (sNDA 20257/S-005)
Comment #:
1). FDA-2013-P-1612-0127
2). FDA-2013-P-1612-0124
3). FDA-2013-P-1612-0112
4). FDA-2013-P-1612-0114
5). FDA-2013-P-1612-0117
6). FDA-2013-P-1612-0121
7). FDA-2013-P-1612-0123
8). FDA-2013-P-1612-0115
9). FDA-2013-P-1612-0120
10). FDA-2013-P-1612-0126
11). FDA-2013-P-1612-0119
12). FDA-2013-P-1612-0113
13). FDA-2013-P-1612-0118
14). FDA-2013-P-1612-0125
15). FDA-2013-P-1612-0122
Title 18, U.S.C., Section 241
Conspiracy Against Rights
This statute makes it unlawful for two or more persons to conspire to injure, oppress, threaten, or intimidate any person of any state, territory or district in the free exercise or enjoyment of any right or privilege secured to him/her by the Constitution or the laws of the United States, (or because of his/her having exercised the same).
My Citizen Petition Comments where censored and not posted despite affirming desire to be posted. Comments posted after Regulatory time limits of CR response and only after numerous emails with Docket Management CC to Senator Tammy Baldwin
21CFR10.3 (e)(2)iii "it raises raises complex issues requiring extensive review and analysis by Agency officials" is a disingenuous statement, as evidence by the lack of rule, Policy and time it took for the FDA to rescind Anchor SPA. 13 days of consideration, yet after a full year CDER has not issued a CP response or a CRL to Amarins sNDA 005.
Again I request Dr. Janet Woodcock fix the issues her subordinates created. I also request this comment be publicly posted.
Thank You for your consideration!
http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-1612-0140
BB
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