Published in Medicine and Law Weekly, October 22nd, 2004
Janet Woodcock, MD, acting FDA deputy commissioner, could not say how long the exhaustive analysis would take or how much it would cost.
"It's a huge undertaking," Woodcock said September 28, 2004.
Columbia University's analysis of pediatric clinical trial data examined just one-tenth of the information contained in adult databases.
That pediatric study, and the FDA's own internal reviews,...
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