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BioPharmaceutical Approvals

“Complete Response” Letters

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

FDA stopped issuing “approvable” and “not approvable” letters in favor of “complete response” letters on Aug. 11, 2008. The following chart lists “complete response” actions that were recently announced, as well as still-pending “approvable” and “not approvable” actions.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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