Skip Navigation

JNCI Journal of the National Cancer Institute 2003 95(8):576-577; doi:10.1093/jnci/95.8.576
© 2003 by Oxford University Press
This Article
Right arrow Full Text 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 Request Permissions
Google Scholar
Right arrow Articles by Christensen, D. E.
Right arrow Search for Related Content
PubMed
Right arrow PubMed Citation
Right arrow Articles by Christensen, D. E.
Social Bookmarking
Add to CiteULike   Add to Connotea   Add to Del.icio.us  
What's this?

Journal of the National Cancer Institute, Vol. 95, No. 8, 576-577, April 16, 2003
© 2003 Oxford University Press

NEWS

FDA Reorganization Intended to Streamline Review Process for Biologics

Damaris E. Christensen

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

In a move applauded by many in the biotechnology industry, the U.S. Food and Drug Administration is moving review of therapeutic biologics—drugs produced from living sources like microorganisms—from its Center for Biologics Evaluation and Research (CBER) to the Center for Drug Evaluation and Research (CDER). The change is intended to speed approval of biologics and streamline the review process.

Initially, several divisions from the Office of Therapeutics Research and Review will be moved from CBER to CDER, said Murray M. Lumpkin, M.D. Lumpkin is the principal associate commissioner at FDA and was the co-chairman of the consolidation working group responsible for implementing the move. The funds to be transferred—nearly $32.9 million, about 20% of CBER’s budget for fiscal year 2003—represent . . . [Full Text of this Article]


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