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Replies to #86520 on Biotech Values
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genisi

11/19/09 9:50 AM

#86524 RE: jbog #86520

The term "Complete Response Letter" sounds very final to my non-English-programed brain, when it actually means there's more to be done... And yes we definitely see more of them and I thought this is since CDER stopped using Approvable Letters and Not Approvable Letters in Aug. 2008, but we also see less approvals, so I suspect it has got to do with "safety first era" at the FDA.