Navigation Links
FDA Announces Changes in Drug Center's Oncology Office
Date:9/12/2011

SILVER SPRING, Md., Sept. 12, 2011 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research's (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

"Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market," said CDER director Janet Woodcock, M.D. "We don't expect these changes to slow down pending applications, in fact, we expect to see greater efficiencies that will better support our work to get cancer treatments to patients."

Richard Pazdur, M.D., who joined the FDA in 1999 and became director of the office in 2005, will continue to serve as the office director. Dr. Pazdur will also continue to head the agency-wide oncology program that coordinates oncology activities within the FDA as well as with external stakeholders. This program will remain in OHOP.  

"As the practice of oncology and the treatments being developed for these diseases have become more complex, we've recognized the need and importance of taking a more disease-specific review approach to these therapies," said Dr. Pazdur. "Reorganizing the office in this manner also aligns FDA with the organizational structure of leading cancer treatment centers, academic programs and the National Cancer Institute."

The previous structure contained three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP), and Division of Biologic Oncology Products (DBOP).

The new structure contains four divisions: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Divi
'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

0

GOOD

Page: 1 2 3

Related medicine technology :

1. Intarcia Announces Presentations of Three Clinical Abstracts at the 47th Annual Meeting of the European Association for the Study of Diabetes
2. Modern Plastics Announces New EVONIK VESTAKEEP® 5000 PEEK Stock Shapes
3. Valeritas Announces $150 Million Financing
4. InterMune Announces Launch of Esbriet® (pirfenidone) in Germany
5. Advanced Health Media, Inc. Announces New SVP Product Delivery
6. Valeant Pharmaceuticals Announces Mailing of Offer and Take-Over Bid Circular to Shareholders of Afexa
7. NeoStem Announces Participation in Multiple September Conferences
8. Anthera Pharmaceuticals Announces Notice of Allowance of U.S. Patent Application Covering A-002 Plus Statin Compositions
9. Pro-Dex, Inc. Announces Fiscal 2011 Fourth Quarter and Full-Year Financial Results Conference Call and Webcast
10. Pharmacyclics Announces Date of Fiscal Year End 2011 Financial Results and Conference Call
11. Campbell Alliance Announces Executive Promotions and Organizational Changes
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/18/2013)... 18, 2013 Although colonoscopy exams prevent many ... most sensitive method for detecting colorectal cancers 2 , ... cases 3 . EndoChoice ® Inc. today unveiled ... improves the accuracy of this procedure and greatly reduces ... be discussing these clinical trial results and featuring the ...
(Date:5/17/2013)... SHANGHAI , May 17, 2013 Medical ... drug nor a biological product. In light of their ... trail evaluations are much more complicated than drug trails ... only evaluates MD safety instead of evaluating both safety ... the US FDA (which is the same as the ...
(Date:5/17/2013)... HILL, N.C. , May 17, 2013 /PRNewswire/ ... how organizations communicate internally. Faced with a constantly ... their strategies and tactics for communicating with internal ... effectiveness of all the strategies, tactics and tools ... In a new study, Best Practices, ...
Breaking Medicine Technology:New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy 2New Study Shows Full Spectrum Endoscopy Procedure Reduces The 'Miss Rate' of Adenomas During Colonoscopy 3Statistical Challenges in Medical Device Trail Evaluation 2Internal Communication Strategies and Tactics that Resonate with Key Stakeholders and Drive Organizational Effectiveness 2
... Eli Lilly and Company,(NYSE: LLY ) ... with the,European Medicines Agency (EMEA) for centralised review ... for the,first-line treatment of advanced non-small cell lung ... more than 85 countries as a,second-line, single agent ...
... insulin glargine, exenatide offered added benefits of, ... with metformin --, AMSTERDAM, Netherlands, Sept. 21 ... Eli Lilly and Company (NYSE: LLY ),today ... insulin glargine on beta-cell function, glycemic control and ...
Cached Medicine Technology:Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 2Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 3Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 4Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 5Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 6Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 7Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 8Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 9Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 10Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 11Lilly Files for European Approval of ALIMTA(R) (pemetrexed for injection) for First-Line Treatment of Non-Small Cell Lung Cancer 12One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 2One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 3One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 4One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 5One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 6One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function 7
(Date:5/20/2013)... 2013 The Multiple System Atrophy Coalition ... of its new Multiple System Atrophy (MSA) Research ... The MSA Coalition’s grass roots fundraising has grown and ... patient/caregiver support to now include education, advocacy and research ... received by The Coalition go directly into a dedicated ...
(Date:5/20/2013)... 2013 Orthopaedic & Spine Center announced ... using SpineFrontier’s FacetFuse Screw System in conjunction with their ... took place on Tuesday, April 16, 2013 at Bon ... The surgery was a facet joint fusion of the ... Dr. Carlson described the case, saying the patient “…had ...
(Date:5/20/2013)... Every 20 seconds, a limb is lost as a ... To date, medical solutions that can change this situation ... from the Industrial Doctoral School and the Department of ... novel medicine for chronic wound treatment that may completely ... wounds are the most severe type of chronic wounds ...
(Date:5/20/2013)... Calif. (PRWEB) May 20, 2013 Ariosa ... risk assessment of Down syndrome and other chromosome conditions, ... twin pregnancies naturally conceived or conceived using the ... be offering fetal X,Y analysis as an option to ... new test allows for the evaluation of fetal sex ...
(Date:5/20/2013)... Cayman, Cayman Islands (PRWEB) May 20, 2013 ... knowledge-based, high tech Special Economic Zone in the ... Referral Network, an initiative to grow the zone’s ... with Cayman’s business-friendly environment and tax benefits are ... many of them referrals from zone channel partners. ...
Breaking Medicine News(10 mins):Health News:Multiple System Atrophy (MSA) Research Grant Program Announced 2Health News:Multiple System Atrophy (MSA) Research Grant Program Announced 3Health News:Multiple System Atrophy (MSA) Research Grant Program Announced 4Health News:Multiple System Atrophy (MSA) Research Grant Program Announced 5Health News:Dr. Jeffrey Carlson Successfully Performs Procedure Using SpineFrontier’s Less Exposure Surgery Technology: FacetFuse 2Health News:Dr. Jeffrey Carlson Successfully Performs Procedure Using SpineFrontier’s Less Exposure Surgery Technology: FacetFuse 3Health News:Discovery of a novel medicine for the treatment of chronic wounds 2Health News:Ariosa Diagnostics Expands Harmony Prenatal Test to Twin Pregnancies and Launches New X,Y Analysis Test 2Health News:Cayman Enterprise City Introduces Referral Network 2Health News:Cayman Enterprise City Introduces Referral Network 3
... University at Buffalo have identified particular genes that are ... a process called DNA promoter hypermethylation. ... normal cell development, to generate proteins that result in ... ,So far, data has been very inadequate regarding the ...
... correlation between an extreme form of sleep disorder, REM Behavior ... ,Patients with RBD have a high probability of ... atrophy, because all of these conditions appear to stem from ... by a team of researchers led by Bradley Boeve at ...
... Angered and alarmed, a good number of yoga enthusiasts and ... yoga overseas. ,Reacting to recent reports of ... experts here feel that the very idea of patenting knowledge ... kind is highly unjustified and when it comes to patenting ...
... regulations requiring equal insurance coverage for mental illness does ... who have children with mental illness, a Yale ... Services Research. ,Prior research has left policymakers ... break the bank nor confer much benefit, said Colleen ...
... the dangers of the rugby scrum could be a key ... suffered by rugby players, says a researcher writing in ... rare, are a major cause of permanently disabling injuries and ... injury prevention programme was introduced by the New Zealand Rugby ...
... after quacks either. A team of researchers in Pennsylvania say ... they have successfully created new hair cells in mice. ... growth can actually be encouraged using a single gene. The ... each of which grows a single hair. ,These ...
Cached Medicine News:Health News:Researchers Have Identified Cancer Promoter Genes 2Health News:Researchers Find Link Between Sleep Disorder and Dementia 2Health News:Yoga Enthusiasts Oppose Patenting Yoga Overseas 2Health News:Coverage for Childrens Mental Illness Reduces Out-of-Pocket Spending 2Health News:Innovative Education Scheme Sees Fewer Rugby Players Suffering Spinal Injuries 2Health News:It is Possible Reverse Hair Loss, US Scientists Say 2
... most advanced system for laser therapy available today. ... optical fiber handpiece that allows to perform linear ... the 20% of the energy reflected by the ... a special gel which optimizes the optical coupling ...
... with the capability of emission at two different ... and ablative capacities.Smart 1064 DW is able to ... ordinary 1064 nm (with powers selectable among 4 ... among 2 and 25 W). This second wavelength ...
... The SmartPulse 10.6 CO2 system was expressly ... in cosmetic surgery. A special source and ... it possible to create particular high energy ... impulses (technically known as 'top-flat shaped') allow ...
... laser is the ideal instrument for safe, ... Plus, the majority of surface lesions can ... range of scar tissue, with a minimum ... with the elimination of anaesthetics, risks and ...
Medicine Products: