Navigation Links
Review and approval of oncology and hematology drugs at FDA from 2005 to 2007
Date:1/29/2010

Over a two and half year period, beginning in 2005 when the U.S. Food and Drug Administration's oncology drug product's office began reviewing marketing applications, a total of 60 new oncology and hematology drugs were reviewed, of which 53 were approved, according to a new article published online January 29 in the Journal of the National Cancer Institute.

To provide an overview of recent regulatory actions by the FDA's Office of Oncology Drug Products in the Center for Drug Evaluation and Research, Rajeshwari Sridhara, Ph.D., of the FDA's Office of Biostatistics, in Silver Spring, Md., and colleagues identified all applications reviewed, as well as actions taken, from July 1, 2005, through December 31, 2007. Their review included "New Drug Application" and "Biologics Licensing Application" approvals.

Marketing applications for 60 new products were reviewed and regulatory action was taken on 58 of them based on a riskbenefit evaluation. Products that demonstrated efficacy and had an acceptable riskbenefit ratio (i.e., the magnitude of the treatment effect was statistically persuasive and clinically meaningful) were granted either regular or accelerated marketing approval. A total of 53 new indications were approved: 39 received regular approval, nine received accelerated approval, and five were converted from accelerated to regular approval. Two applications were withdrawn before action was taken, and five were not approved.

Approvals were based on various study designs and primary outcomes or endpoints. Some approvals were from single-arm, non-randomized controlled trials in cases when the FDA deemed it impractical to conduct randomized studies.


'/>"/>

Contact: Steve Graff
jncimedia@oxfordjournals.org
301-841-1285
Journal of the National Cancer Institute
Source:Eurekalert

Page: 1

Related medicine news :

1. New review suggests caution on drugs to raise good cholesterol
2. Virginia Tech Review Panel Calls For Reform of Mental Health Treatment Law
3. Arbios Systems, Incs Q2/07 Analyst Review Issued by Scimitar Equity Research, Inc.
4. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
5. FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
6. Peer-Reviewed, Online Database Showcases Local, County and State Pandemic Planning
7. InstaCare Corp. Reviewing M&A Plans
8. CCF Reviews Contents of SCHIP Reauthorization Bill Legislation Places SCHIP on Solid Path
9. Sunrise Provides Status Report on Special Independent Committee Investigation; Provides Updates on Managements Internal Control Review Efforts and on Legal Proceedings
10. Multicountry review shows that Bug Buster Kits reduce head lice and social stigma
11. MaxLife Fund Corp. retains the Law firm, Anslow & Jaclin, LLP of Manalapan, N.J., to review MaxLife Fund Corp. options to be listed on the NASDAQ Capital Market
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... , ... June 25, 2016 , ... Austin residents seeking ... American College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical ... effective treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by ...
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... ... 25, 2016 , ... As a lifelong Southern Californian, Dr. Omkar Marathe earned ... the David Geffen School of Medicine at UCLA. He trained in Internal Medicine at ... fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where he had the opportunity ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
(Date:6/24/2016)... Los Angeles, CA (PRWEB) , ... June 24, 2016 , ... ... plastic surgery procedures that most people are unfamiliar with. The article goes on to ... known procedures, but also many of these less common operations such as calf and ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Bay Area ... Network,s Dean Center for Tick Borne Illness ... and Rehabilitation, MIT Hacking Medicine, University of California, ... today announced the five finalists of Lyme ... disease.  More than 100 scientists, clinicians, researchers, entrepreneurs, ...
(Date:6/24/2016)... Dehaier Medical Systems Ltd. (NASDAQ: DHRM ) ... medical devices and wearable sleep respiratory products in ... with Hongyuan Supply Chain Management Co., Ltd. (hereinafter referred ... to develop Dehaier,s new Internet medical technology business. ... Hongyuan Supply Chain,s sales platform to reach Dehaier,s dealers ...
(Date:6/24/2016)... LEXINGTON, Mass. , June 24, 2016   ... specialty pharmaceutical company developing innovative inhaled drugs, announced today ... when Russell Investments reconstituted its comprehensive set ... 2016. "This is an important milestone for ... "It will increase shareholder awareness of our progress in ...
Breaking Medicine Technology: