TITLE

Trouble at the office

AUTHOR(S)
Allison, Malorye
PUB. DATE
September 2008
SOURCE
Nature Biotechnology;Sep2008, Vol. 26 Issue 9, p967
SOURCE TYPE
Academic Journal
DOC. TYPE
Article
ABSTRACT
The article discusses an investigation into the role of surrogate endpoints used in the approval of drugs by the U.S. Food and Drug Administration's (FDA) Office of Oncology Drug Products (OODP). An example is given of cancer treatment drugs, such as Avastis used in the treatment of breast cancer, and another used to treat colon cancer, which were approved based on the survival data of progression-free patients. Progression-free survival data is a surrogate trial endpoint that oncologists are hoping will be used more often. Topics include the slowdown of oncology drug development and its possible causes, comments from several notable oncologists, and an examination of research data by oncologist Charles Bennett at Northwestern University regarding the FDA's approval process.
ACCESSION #
34198246

 

Related Articles

  • Oncology Drugs Have Various Endpoints.  // BioWorld Today;2/22/2010, Vol. 21 Issue 34, p3 

    The article presents an analysis of data, which revealed that the Office of Oncology Drug Products at the U.S. Food and Drug Administration (FDA) approved 53 cancer indications for drugs and biologics between July 2005 to the end of 2007.

  • ChemGenex obtains FDA complete response letter for leukemia drug.  // PharmaWatch: Biotechnology;May2010, Vol. 9 Issue 5, p12 

    The article reports that biopharmaceutical company ChemGenex Pharmaceuticals Ltd. has reported that U.S. Food & Drug Administration's (FDA) Office of Oncology Drug Products issues a complete response letter on the new drug application for Omapro in treating adults with chronic myeloid leukeumia.

  • ChemGenex obtains FDA complete response letter for leukemia drug.  // PharmaWatch: Cancer;May2010, Vol. 9 Issue 5, p12 

    The article reports on the complete response letter received by ChemGenex Pharmaceuticals Ltd. issued by the Food and Drug Administration's (FDA's) office of Oncology drug Products. It mentions that the complete response letter was issued by FDA regarding the new drug application for Omapro for...

  • No Strings Attached. Peters, Rita C. // Drug Discovery & Development;May2012, Vol. 15 Issue 5, p4 

    The author discusses the implications of the reauthorization of the Prescription Drug User Fee Act (PDUFA) in the U.S. She explains that the legislation must be renewed before its expiration date on September 30, 2012 because it may compromise the drug review process and may force the Food and...

  • 12 Key Steps to Address USP Changes.  // Pharmaceutical Processing;Aug2009, Vol. 24 Issue 8, p22 

    The article discusses key procedures which the pharmaceutical industry should consider for them to be prepared in addressing the changes in the United States Pharmacopoeia (USP) General Microbiology. These suggestions from life science products provider Celsis International PLC include...

  • New Indications Are on the Rise.  // Chain Drug Review;3/28/2011, Vol. 33 Issue 6, p78 

    The article reports on the increase of modified indication approvals for prescription drugs in the U.S.

  • The Complexities of Litigating Generic Drug Exclusion Claims in the Antitrust Class Action Context. Royall, M. Sean; Lipton, Joshua // Antitrust Magazine;Spring2010, Vol. 24 Issue 2, p22 

    The article focuses on the complexities involved in litigating generic drug exclusion claims made by the branded pharmaceutical manufacturers under the U.S. antitrust law. It discusses the Hatch-Waxman Act which permits a generic manufacturer to file an Abbreviated New Drug Application, to be...

  • FDA Designations for Therapeutics and Their Impact on Drug Development and Regulatory Review Outcomes. Kesselheim, AS; Darrow, JJ // Clinical Pharmacology & Therapeutics;Jan2015, Vol. 97 Issue 1, p29 

    New prescription drugs receive approval from the US Food and Drug Administration (FDA) based on tests establishing safety and adequate and well-controlled trials demonstrating 'substantial evidence' of efficacy. However, a number of legislative and regulatory initiatives, the most recent being...

  • Market watch: Upcoming market catalysts in Q3 2010. Hay, Michael // Nature Reviews Drug Discovery;Jul2010, Vol. 9 Issue 7, p507 

    The article focuses on the critical test for regulatory approval of anti-obesity drugs phentermine/topiramate from Vivus Inc. and lorcaserin hydrochloride from Arena Pharmaceuticals Inc. conducted by the Food and Drug Administration in the U.S. It notes that panel members of the FDA advisory...

Share

Read the Article

Courtesy of THE LIBRARY OF VIRGINIA

Sorry, but this item is not currently available from your library.

Try another library?
Sign out of this library

Other Topics