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JNCI Journal of the National Cancer Institute 2005 97(23):1720-1721; doi:10.1093/jnci/dji441
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© 2005 Oxford University Press

NEWS

Pediatric Drug Trials Facing Some Obstacles

Joel B. Finkelstein

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

At a recent meeting of a U.S. Food and Drug Administration advisory panel, experts expressed a mixture of hope and disappointment after reviewing early attempts to conduct federally mandated studies of newly approved oncology drugs in children.

"The frustration in the room was really not so much with the pace of the studies as it was with the lack of early communication in the planning and consideration of the studies," said Gregory Reaman, M.D., chairman of the FDA's Oncologic Drugs Advisory Committee's pediatric subcommittee.


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  		Gregory Reaman

 
At the meeting last month, industry representatives presented the status of pediatric studies for Clolar (clofarabine) in refractory leukemia, Neulasta (pegfilgrastim) for neutropenia, and Kepivance (palifermin) for oral mucositis.

Clofarabine was granted accelerated . . . [Full Text of this Article]

Obstacles

Evolving Process


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