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BioPharmaceutical Regulation Approvals

Biologics Approved In 2011

This article was originally published in Pharmaceutical Approvals Monthly

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Executive Summary

FDA transferred review of most therapeutic biologics to the Center for Drug Evaluation & Research on Oct. 1, 2003. The Center for Biologics Evaluation & Research continues to review other biologics, including vaccines, cellular products, antitoxins and immunoglobulins.

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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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