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Posts Tagged ‘NCI’
LATEST POSTS
- 11/10/2008 - New FDA Commissioner - Change or More of the Same
- 10/27/2008 - CareToLive Sends Writ to Supreme Court of the United States
- 10/09/2008 - What is a Life Worth?
- 09/08/2008 - CareToLive Strikes Back!
- 08/28/2008 - CareToLive Continues Fight for Prostate Cancer Patients Rights!
- 08/15/2008 - THE STONEWALLING CONTINUES
- 08/04/2008 - NCI FOIA Response
- 08/04/2008 - Where it stands…CareToLive vs. FDA (long winded version)
- 07/25/2008 - Ed Silverman from Pharmalot Bags It!
- 07/23/2008 - 7/23/08
MOST POPULAR
- Sleepless in Asentar
- The FDA is uncaring, the world won’t change their thought process and meanwhile Congress remains asleep at the wheel, when it comes to Provenge for the terminally ill.
- Michael Milken and the Prostate Cancer Foundation's Foul Balls
- Are Congress and the FDA missing the big picture?
- Corruption at Its Finest
- Supplemental Memorandum Plaintiff CareToLive
- The Time is NOW!
- 3 "Leaked" Letters & So Much More
- Get On The Bus Gus!
- The FDA Is Out Of Control
WHATS GOING ON
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
This Is An Emergency!
We rallied outside the FDA building in Rockville, Maryland on September 18th. Now there are buses riding around Rockville and Washington, D.C., further protesting the shenanigans that took place inside the FDA building, as well as outside.
The FDA has gotten caught up with Wall Street. While it is supposed to be busy with evaluating food and drugs, its employees just can't keep their eyes off the money. So that is how decisions are being made these days.
WE'LL BE BACK
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
These people traveled from all across the country to protest outside the FDA Building in Rockville, Maryland. The FDA has stopped a safe and effective treatment from getting to men who need it now. The treatment is called Provenge and it treats men who have late stage prostate cancer.
The FDA appointed a panel of experts to help it decide on the safety and efficacy of Provenge. That panel voted 17-0 that Provenge was safe. And it voted 13-4 that Provenge showed substantial evidence it worked. And yet the FDA delayed it. Now it could be a year, a year and a half or it could be three years. It could be forever.
These people will keeping coming back to Rockville and they hope others will join them until the courts, the FDA, Congress or somebody does something about this travesty.
NCI FOIA Response
August 4th, 2008 | Posted by CTLIf you haven’t yet had a chance to read the FOIA response from the National Cancer Institute, read it here.
Popularity: 37%
Tags: foia response, NCI
Posted in The Cause, The Dysfunctional FDA, The Lawsuit | Post a Comment »
FDA Responds to CareToLive Complaint for Violation of Freedom of Information Act
February 6th, 2008 | Posted by CTLCareToLive has received an answer from the FDA to our Complaint that the FDA has not been forthcoming with all of the Freedom of Information (FOI) documents that we requested and are entitled to under the Freedom of Information Act (FOIA). Our Attorney Kerry Donahue will attend a Pretrial Hearing on March 5, 2008.
CareToLive requested all documents, letters, emails and /or correspondence from the National Cancer Institute (NCI) to the FDA or those acting as advisors to the FDA, concerning the BLA filed by Dendreon Corporation for fast track appproval of Sipuleucel-T, known under its marketing name of Provenge between January 1, 2007 and May 30, 2007. We seek to understand the role that the NCI played with regards to the process that resulted in the non approval of Provenge on May 9, 2007. We also requested all information pertaining to the roles played by Dr. Scher, Dr. Hussain and Dr. Fleming including Alison Martin and anyone else at NCI in regards to the FDA decision or with those working with the FDA, as as Scher, Hussain and Fleming.
CareToLive also requested all letters written to the FDA or prepared by the FDA and purported to be from Dr. Scher, Dr. Hussain and Doctor Fleming between March 29, 2007 and April 30, 2oo7 regarding the BLA submitted for Provenge, including the envelope or other means of communication whereby the FDA received such letters and a copy af any record for those letters then being disclosed to any media or other persons or specifically a publication call “The Cancer Letter”, including the means of communication of the Cancer Letter of the Scher, Hussain and Fleming letter from the FDA or its employees to outside persons, publications or companies. Continue Reading FDA Responds to CareToLive Complaint for Violation of Freedom of Information Act »
Popularity: 47%
Tags: , Alison Martin, Andrew Von Eschenbach, Care To Live, CareToLive, CareToLive vs. FDA, FDA, foia, Freedom of Information Act, Howard Scher, Howard Streicher, Kerry Donahue, maha hussain, National Cancer Institute, NCI, Thomas Fleming
Posted in The Cause, The Lawsuit | Post a Comment »