Skip Navigation

JNCI Journal of the National Cancer Institute 2005 97(24):1802-1804; doi:10.1093/jnci/dji456
This Article
Right arrow Full Text Freely available
Right arrow FREE Full Text (PDF) Freely available
Right arrow Alert me when this article is cited
Right arrow Alert me if a correction is posted
Services
Right arrow Email this article to a friend
Right arrow Similar articles in this journal
Right arrow Similar articles in PubMed
Right arrow Alert me to new issues of the journal
Right arrow Add to My Personal Archive
Right arrow Download to citation manager
Right arrow Search for citing articles in:
ISI Web of Science (2)
Right arrow Request Permissions
Google Scholar
Right arrow Articles by Finkelstein, J. B.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Finkelstein, J. B.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

© 2005 Oxford University Press

NEWS

Accelerated Approval Regulations May Need Overhaul, Panel Suggests

Joel B. Finkelstein

The first 10% of the full text of this article appears below.

Accelerated approval has allowed many orphan drugs to come to market sooner—and in some cases, perhaps too soon, said oncology experts who advise the U.S. Food and Drug Administration.

Accelerated approval allows drugs for life-threatening diseases, including cancer, to be given marketing approval by the FDA based on data from less rigorous studies than are required for full approval. The approval is given on the condition that companies conduct postmarketing confirmatory studies.

Those studies have proven difficult to complete and are raising some ethical concerns as companies move them overseas in attempts to meet accrual targets.

After hearing presentations about several such efforts, members of the Oncologic Drug Advisory Committee (ODAC) called for revisions to the study requirements meant to move the drugs from accelerated . . . [Full Text of this Article]

Similar Problems

Good Effort


Add to CiteULike CiteULike   Add to Connotea Connotea   Add to Del.icio.us Del.icio.us    What's this?


This article has been cited by other articles:


Home page
 JCOHome page
E. A. Richey, E. A. Lyons, J. R. Nebeker, V. Shankaran, J. M. McKoy, T. H. Luu, N. Nonzee, S. Trifilio, O. Sartor, A. B. Benson III, et al.
Accelerated Approval of Cancer Drugs: Improved Access to Therapeutic Breakthroughs or Early Release of Unsafe and Ineffective Drugs?
J. Clin. Oncol., September 10, 2009; 27(26): 4398 - 4405.
[Abstract] [Full Text] [PDF]