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BioPharmaceutical Clinical Trials Post Market Regulation & Studies

The Xalkori Clinical Trial Package

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

Because Pfizer had already started its Phase III trials before filing for accelerated approval, FDA was able to piggy-back most of its post-marketing requirements onto ongoing studies.

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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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