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6:50 PM
Jan 18, 2007
 |  BC Extra  |  Top Story

FDA misses mark on '05 reviews

FDA's performance in completing reviews of NDAs declined sharply for applications with Priority Review submitted in fiscal 2005, according to data released by FDA on Thursday. The agency failed to act -- issue an approval, or an approvable or not approvable letter -- on 14% of original NDAs with Priority Review within six months of receiving the...

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