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BioPharmaceutical

Torisel Review Uncovers Protocol Violations That Extended PDUFA Date

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Wyeth’s failure to follow protocol-defined RECIST criteria for measuring tumor response in the pivotal trial for its renal cell carcinoma therapy Torisel was the reason that the drug’s user fee date was extended, according to FDA review documents.

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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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