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:1/15/2014)... (PRWEB) January 15, 2014 Cynvenio, a ... management through the genomic analysis of tumor cells in ... Finder™, a web-based cancer decision support application powered by ... with Cynvenio’s ClearID™ genomic test, Therapy Finder will provide ...
(Date:1/15/2014)... RedBrick Health , a fast-growing leader in consumer health ... EmblemHealth , the New York -based ... RedBrick Compass health assessment, combined with the RedBrick Journeys ... EmblemHealth is among the first health plans in the ...
(Date:1/15/2014)... 2014 A study has been launched to ... 1 track could help to tackle the problem of obesity. ... (a GP surgery based in Stowmarket) and academics at University ... Telemetry technology, which is inspired by equipment used to ...
(Date:1/15/2014)... 2014 Two champions of science, technology, ... of an annual competition for middle and high school ... innovative STEM study. The competition presents students with real-world ... Engineering Aptitude, Mathematics, and Sciences is a program ...
Breaking Biology Technology:Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 2Cynvenio Offers New Breast Cancer Therapy Finder Application for its ClearID Breast Cancer Genomic Test 3EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 2Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 3Formula 1 Technology Tackles Obesity in Unique Healthcare Partnership 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 5
... world of the 21st century owes a tremendous amount ... finely control the flow of electrical charges using increasingly ... continue to race ahead, researchers at the University of ... by replacing electricity with light. "Looking at the ...
... Springboard Enterprises has over a decade of experience ... potential investors and corporate partners.  Today they launch ... to fast track the growth of the best ... from around the world. The search is on ...
... and AMSTERDAM, Feb. 23, 2012   Rubicon Genomics, ... pre-analytical processes to improve the capabilities and ... today announced a clinical supply agreement with ... whole genome RNA amplification technology.  Agendia will ...
Cached Biology Technology:Penn researchers build first physical 'metatronic' circuit 2Penn researchers build first physical 'metatronic' circuit 3Penn researchers build first physical 'metatronic' circuit 4The Search Is On for the Next Big Life Science Innovation 2The Search Is On for the Next Big Life Science Innovation 3Rubicon Genomics and Agendia Sign Agreement for Use of TransPLEX® Whole Genome RNA Amplification Technology With Symphony™ Cancer Diagnostics 2Rubicon Genomics and Agendia Sign Agreement for Use of TransPLEX® Whole Genome RNA Amplification Technology With Symphony™ Cancer Diagnostics 3
(Date:4/17/2014)... years ago, Katia Silvera , a postdoctoral scholar at ... a field trip in a mountainous area in central Panama ... before. , Unable to identify it, they contacted German Carnevali, ... to be an unnamed species. So Carnevali recently named it ... the genus name, comprising about 40 species in the world. ...
(Date:4/17/2014)... available in German . ... protection money demanded of him, he can expect his premises ... as fear of the consequences is enough to make restaurant ... birds, which lay their eggs in other birds, nests. If ... parasites take their revenge by destroying the entire nest. Consequently, ...
(Date:4/17/2014)... deforestation and fragmentation of forests in the Amazon ... forests, contributing to rapid and widespread forest loss ... researchers., The findings show that forests in the ... droughts coupled with forest fires lead to large-scale ... Jennifer Balch, assistant professor of geography, Penn State. ...
Breaking Biology News(10 mins):Orchid named after UC Riverside researcher 2Orchid named after UC Riverside researcher 3Fear of the cuckoo mafia 2Fear of the cuckoo mafia 3Drought and fire in the Amazon lead to sharp increases in forest tree mortality 2Drought and fire in the Amazon lead to sharp increases in forest tree mortality 3
... antibacterial protein targeted against E. coli O157:H7 may offer ... infections, as demonstrated in a study published in the ... Results in an animal model of E. coli ... by AvidBiotics, Inc., could prevent or treat E. ...
... YORK, November 20, 2011 In a new study scientists ... of smell can be improved. The new findings, published online ... ways to reverse the loss of smell due to aging ... senses, explains Donald A. Wilson, PhD, professor of child and ...
... in Nature Medicine describes how different types of immune ... regrow bone and tissue, bringing into sharp focus the ... cell regeneration. The study, conducted at the Center ... Dentistry of USC, examined how mice with genetic bone ...
Cached Biology News:Targeted antibacterial proteins may offer antibiotic alternative 2Targeted antibacterial proteins may offer antibiotic alternative 3A failing sense of smell can be reversed 2
Polyclonal Antibody to CLAN...
Request Info...
IRF7 Immunogen: Synthetic peptide corresponding to residues E(463) G T Q R E G V S S L D S S S(477) of human IRF7. Storage: -20 C, Avoid Freeze/Thaw Cycles...
Rabbit polyclonal to TetR ( Abpromise for all tested applications). Antigen: Synthetic peptide: AQKLGVEQPTLYWHVKNKR, corresponding to amino acids 31 - 49 of TetR...
Biology Products: