CBER’s 2012 Approval Count Is Average, But Its On-Time Review Performance Exceeded Expectations
This article was originally published in Pharmaceutical Approvals Monthly
FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).
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