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Cimzia Met "Minimum Necessary" CDER Standard With CBER-Advised Trials

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Insufficient clinical evidence for one aspect of Cimzia’s Crohn’s disease indication came close to derailing FDA’s review of the UCB biologic, but approval was salvaged by FDA’s interest in maintaining consistency between its drugs and biologics centers in agreements made with sponsors during development.

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