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Drug Industry Daily
Aug. 8, 2012 | Vol. 11 No. 155
Electronic Biological Product Deviation Reports May Trigger ‘Direct’ Recall, CBER Officials Say
TAMPA, Fla. — Now that CBER’s all-electronic Direct Recall Classification (DRC) program has been extended to non-blood products, problems with biologic drugs flagged in electronic biological product deviation reports (eBPDRs) may trigger recalls of those products under the program.
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