Navigation Links
Steven Zecola Files a Citizen's Petition with the FDA for a New Approach to Address Metastatic Cancer
Date:6/24/2013

Washington, DC (PRWEB) June 24, 2013

Cancer causes over 550,000 deaths in the United States each year 1_/, and 90% of those deaths derive from metastatic cancer. 2_/ Yet, only 8% of the federal funding for cancer goes toward metastatic cancer. 3_/

Additionally, under the FDA’s procedures for clinical trials, a new drug takes 12 years on average to make it through the FDA process 4_/ at an average cost of over $1 billion. 5_/

The burden imposed by the FDA’s rules is even greater for the compounds designed to treat metastatic cancer. First, the FDA’s rules require the compounds to reduce the primary tumor, but that is not the purpose of these compounds and they often do not pass this test. 6_/ Second, the objective of the compounds is to delay the recurrence of cancer, which by definition implies an even further elongated trial approval process and even more costs.

Nor does the FDA recognize the poor prognosis of metastatic cancer patients to establish distinct procedures for clinical trials with these participants. 7_/ Yet many of these patients have been told to get their affairs in order and many would be willing to take greater risks than others to participate in research. But the FDA applies its standard safety guidelines to the trials with these patients which cover six categories of safety including adverse events unrelated to the drug. 8_/

The Petition requests the FDA to adopt procedures specific to the circumstances surrounding metastatic cancer. For example, the trial design to ensure a compound’s efficacy would be limited to two phases. _9/

With the requested changes in place, the journey to finding a cure for metastatic cancer can begin in earnest.

The Petition can be read at: http://www.regulations.gov/#!documentDetail;D=FDA-2013-P-0695-0001

Th
'/>"/>

Source: PRWeb
Copyright©2012 Vocus, Inc.
All rights reserved

Page: 1 2 3

Related biology technology :

1. Director of Proteomics at the Broad Institute of MIT and Harvard, Steven Carr, to Deliver Pittcon 2014 Wallace H. Coulter Plenary Lecture
2. Representatives Betty McCollum (MN) and Steven LaTourette (OH) to Receive USGS Coalition Leadership Award
3. Ceres Expands Board of Directors with former BP Chief Scientist and Undersecretary of Energy Steven Koonin
4. Stevenage Bioscience Catalyst to Welcome Cambridge University Researchers
5. Stevenage Bioscience Catalyst Opens With Exciting Year Ahead
6. Cellular Dynamics International Files Registration Statement for Proposed Initial Public Offering
7. Dr. Rongxiang Xu, Patent Owner of Damaged Organ Regeneration, a Top Priority Addressed in the 2013 Presidential State of The Union, Files Lawsuit Against Dr. Yamanaka for Deception
8. Dr. Rongxiang Xu, Patent Owner of Damaged Organ Regeneration, a Top Priority Addressed in the 2013 Presidential State of The Union, Files Lawsuit Against 2012 Nobel Laureate Dr. Yamanaka for Deception
9. 3SBio Inc. Files Annual Report on Form 20-F for Fiscal Year 2012
10. Early Stage Drug Delivery Technologies: 62 Profiles of Start-ups and Emerging Companies
11. Regado Biosciences, Inc. Files Registration Statement for Proposed Initial Public Offering
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/16/2015)... /PRNewswire/ - Portage Biotech Inc. ("Portage" or "the Company" ... pleased to announce that the Company will be presenting ... to be held in London, UK ... Mr. James Mellon , a director of Portage, ... key programs at its subsidiaries, Portage Pharmaceuticals Ltd. ("PPL"), ...
(Date:4/16/2015)... ON , April 16, 2015 /CNW/ - Bioenterprise Corporation ... its newest office in Charlottetown , ... the Prince Edward Island ADAPT Council for the commercialization ... looking forward to working with PEI ADAPT.  They have ... for more than a decade," explains Dave Smardon ...
(Date:4/16/2015)... AZ (PRWEB) April 16, 2015 A ... makes it easier for research institutions to learn how ... clinical data. , The timing is ideal since Apple ... Tuesday. Research Kit is an open-source framework for developing ... It provides a way for researchers to collect secure ...
(Date:4/16/2015)... BURLINGAME, Calif. , April 16, 2015  Scientists ... session, "New Drugs on the Horizon," at the American ... Philadelphia, PA on Sunday, April 19, ... , Ph.D., Cleave,s Director of Biology, will present new ... CB-5083, a first-in-class, oral inhibitor of p97, a critical ...
Breaking Biology Technology:Portage to Present at Master Investor 2015 in London, UK 2Portage to Present at Master Investor 2015 in London, UK 3Portage to Present at Master Investor 2015 in London, UK 4Bioenterprise Corporation Expands into the Maritimes 2Infographic Illustrates Potential for Research Kit to Impact Clinical Research 2Infographic Illustrates Potential for Research Kit to Impact Clinical Research 3Cleave Biosciences to Participate in Special Session "New Drugs on the Horizon" at AACR Annual Meeting 2015 2Cleave Biosciences to Participate in Special Session "New Drugs on the Horizon" at AACR Annual Meeting 2015 3
... NEW YORK, Oct. 10, 2011 In response to Rubicon,s ... E. Sandell sent today the following letter to Rubicon,s Board ... 3 7 - 9 Fanshawe Street Auckland New Zealand Attn: ... Dear Gentlemen: As you are aware, funds ...
... Iceland, October 9, 2011 Scientists at deCODE ... and the USA today report the discovery of low frequency ... gout, a common inflammatory arthritis, and serum uric acid levels. ... is published today in the online edition of Nature ...
... In support of Breast Cancer Awareness LensWay.co.uk will ... There are over 50 styles to choose from and starting ... range of pink glasses please visit the following page: ... For women in the UK breast cancer is the most ...
Cached Biology Technology:Sandell Asset Management Seeks Sale of Rubicon & Tenon, Expansion of Board 2Sandell Asset Management Seeks Sale of Rubicon & Tenon, Expansion of Board 3deCODE Genetics, in Collaboration with Academic Colleagues and Illumina, Discovers Two Rare Variants that Affect the Risk of Gout and Serum Uric Acid Levels 2deCODE Genetics, in Collaboration with Academic Colleagues and Illumina, Discovers Two Rare Variants that Affect the Risk of Gout and Serum Uric Acid Levels 3Buy Pink Glasses From LensWay and £20 Will be Donated to Breast Cancer Research 2
(Date:3/24/2015)... DUBLIN , Mar. 24, 2015 Research and ... addition of the "Global Iris Recognition Market 2015-2019" ... forecast the Global Iris Recognition market to grow at ... This report covers the present scenario and ... for the period 2015-2019. To calculate the market size, ...
(Date:3/23/2015)... SoundView Technology Group issues a new research update ... Wocket smart wallet. SoundView was one of the selected user groups ... the Wocket in multiple scenarios and outlets. ... retailers, making both debit and credit card payments.  ... the company meets their plans in 2015, it would push ...
(Date:3/20/2015)... DUBLIN , Mar. 20, 2015 Research ... announced the addition of the "India Sensors ... their offering. The sensor market is ... through 2020 Consumer electronics, automotive, industrial ... for sensors in the country. In addition, adoption ...
Breaking Biology News(10 mins):Global Iris Recognition Market 2015-2019 with 3M Cogent, Bioenable Technologies, Cross Match Technology, Iris ID Systems & Safran Dominating 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 2Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 3Technology Research Note Update from SoundView; Real-World Usage and Feedback of Wocket Smart Wallet at CVS, Whole Foods and other Retailers 4India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 2India Sensors Market Forecast and Opportunities 2020 - STMicroelectronics held the largest share in 2014 3
... the nutrient-poor soils in which they grow by trapping ... of the genus Nepenthes were thought to capture their ... paper in this weeks PLoS ONE, Laurence Gaume and ... CNRS, working respectively in the University of Montpellier and ...
... A joint Yale-Peking University center that aims to ... will receive five years of continued and expanded support ... technology. The company will fund student exchanges and ... Peking-Yale Joint Center (PYC) for Plant Molecular Genetics and ...
... CO 2 emissions from using coal are set to double ... of mitigating global climate change. In view of the essential ... minimise emissions where coal is used. The British ... Coal (NZEC) Phase 1 study in Beijing, China today. The aim ...
Cached Biology News:Carnivorous plants use pitchers of 'slimy saliva' to catch their prey 2Monsanto expands sponsorship for Peking-Yale Joint Agrobiotechnology Center 2UK scientists lead China closer to carbon capture and storage 2
... Gene Pulser Xcell microbial system, 100 ... used for electroporation of bacterial and ... main unit, PC module for exponential ... sterile cuvettes (5 each of 0.1 ...
... Array (MSTA) slides were designed to study protein ... multiple species. Tissue slices from three different ... can then be treated as a single histological ... situ hybridization. This format allows a ...
... is used to predict the ... sequence up to 3,200 bases, ... of primers and GC clamps ... gradient gel electrophoresis (DGGE), constant ...
... RNAi Services offer you a full ... studies. B-Bridges advanced design parameters, effective ... ensure that you obtain quality results ... Design Service utilizes their proprietary B-Algo ...
Biology Products: