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An FDA Nominee, Biologics Reviews Move to CDER

Executive Summary

The FDA's recent announcement that the responsibility for reviewing biologics would be transferred from the Center for Biological Research (CBER) to the Center for Drug Evaluation and Research came amidst growing industry and congressional criticism about CBER's handling of Biologics Licensing Applications (BLAs). But the FDA's failure to spell out the details of the reorganization leaves many questions unanswered, among them: what will be the implications for biogenerics; how will CBER's funding be affected; and what will be the impact on pending BLAs?

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