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:7/30/2014)... , July 30, 2014 Regulus Therapeutics ... company leading the discovery and development of innovative medicines ... results and highlights for the quarter ended June 30, ... financial markets close. Regulus will host ... 2014, at 5:00 pm Eastern Daylight Time to discuss ...
(Date:7/30/2014)... N.Y. and PARIS , ... and Sanofi (EURONEXT: SAN and NYSE: SNY) today announced ... and Drug Administration (FDA) rare pediatric disease priority review ... submission for alirocumab.  The priority review voucher entitles the ... provides for an expedited 6-month review from the filing ...
(Date:7/30/2014)... 2014 W. R. Grace & ... the REVELERIS® Prep purification system , a ... and other researchers to perform both flash and ... , With the REVELERIS® Prep purification system, researchers ... modes with a simple touch of the screen, ...
(Date:7/30/2014)... , July 30, 2014  Decision Resources ... and medical directors in the United ... of biosimilar market penetration will be the level ... (MCOs) and the expected lower cost to patients. ... biosimilars that meet their pricing expectations in order ...
Breaking Biology Technology:Regulus Announces Timing for Second Quarter 2014 Financial Results Webcast and Conference Call 2Regulus Announces Timing for Second Quarter 2014 Financial Results Webcast and Conference Call 3Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission 2Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission 3Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission 4Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission 5Regeneron and Sanofi Announce Plan to Use Priority Review Voucher For Alirocumab U.S. FDA Submission 6Grace Launches New REVELERIS® Prep Purification System 2Surveyed U.S. Payers Expect Cost Savings to MCOs and Patients to be the Strongest Drivers of Biosimilar Uptake 2Surveyed U.S. Payers Expect Cost Savings to MCOs and Patients to be the Strongest Drivers of Biosimilar Uptake 3
... March 17 The following was issued,today by the ... president & CEO, Greater Baltimore Committee, 140 company ... WHAT:, The third annual Greater Baltimore Region Bioscience ... 8:00 a.m. / Breakfast & Registration, 8:45 - ...
... 17 Mercury Therapeutics,Inc. (MTI), a company ... targeted drugs, announces that it has retained ... on its strategic and partnering,opportunities, with the ... This appointment follows a significant amount ...
... ST. LOUIS, March 17 (Nasdaq: SIAL ) ... holding its 2008 Annual,Business Review on Wednesday, March 19, ... at 2909 Laclede, St. Louis, Mo. 63103, The ... by 12:30 p.m. CDT,and will also be webcast over ...
Cached Biology Technology:Greater Baltimore Committee to Announce Winners of Third Baltimore Region Bioscience Awards at Ceremonies on March 18 2Mercury Therapeutics, Inc: Marquant Appointed to Advise on Strategic and Partnering Opportunities 2Mercury Therapeutics, Inc: Marquant Appointed to Advise on Strategic and Partnering Opportunities 3
(Date:7/30/2014)... Queen in Lewis Carroll,s Through the Looking Glass, ... University of Singapore improved a 35-year-old ecology model ... to millions of years. , The new model, ... the "Red Queen Effect," an evolutionary hypothesis introduced ... suggests that organisms must constantly increase their fitness ...
(Date:7/30/2014)... A deep-sea octopus protected and tended her eggs until ... published July 30, 2014 in the open-access journal ... Aquarium Research Institute and colleagues. , Octopuses typically have ... females protect and take care of their fertilized eggs ... eggs for 1 to 3 months, but little is ...
(Date:7/30/2014)... Chemical Society (ACS) announced today that David L. Kaplan, ... Biomaterials Science & Engineering as editor-in-chief. With the ... new journal will feature high-quality research in the rapidly ... naturally derived materials that interact with living or biological ... reflects the tremendous growth in the field of biomaterials ...
Breaking Biology News(10 mins):Classic Lewis Carroll character inspires new ecological model 2Classic Lewis Carroll character inspires new ecological model 3Deep-sea octopus has longest-known egg-brooding period 2ACS Biomaterials Science & Engineering: Brand-new journal launches in 2015, names editor 2
... is also available in Chinese on EurekAlert! ... A new laser-beam steering system that aims and focuses bursts ... has been demonstrated by collaborating researchers from Duke University and ... Applied Physics Letters , published by the American Institute of ...
... the RMS Titanic, which is contributing to its deterioration. ... the exterior of ships and underwater metal structures such ... findings in the latest issue of the International ... 8 December, isolated the micro-organisms from a ,rusticle, collected ...
... book, Illinois Birds: A Century of Change, literally took 100 ... Illinois was conducted from 1906-1909. It was repeated from 1956-1958 ... When the 100-year anniversary of that first survey was approaching, ... seized the window of opportunity to do it again and ...
Cached Biology News:Tiny laser light show illuminates quantum computing 2New microscopic life aboard the RMS Titanic 2New book on 100 years of Illinois birds 2New book on 100 years of Illinois birds 3New book on 100 years of Illinois birds 4
...
... Rabbit Antibody to CRF ... with the ovine CRF sequence ... Cells and fibres are found ... of rat brain in colchicine ...
...
Alexa Fluor 647 anti-mouse Qa-2...
Biology Products: