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News Analysis
Nature Reviews Drug Discovery 7, 634–635 (1 August 2008) | doi:10.1038/nrd2650
News in brief
Abstract
No more FDA approvable, non-approvable letters From 11 August 2008 the FDA will send a complete response letter when a drug application is not ready for approval. The lowdown: Back in 2004, the FDA published a proposed rule change to replace approvable and non-approvable letters with a single complete response letter to “adopt a more consistent and neutral mechanism to convey that [the agency] cannot approve an application in its present form.
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