Biological product deviation report summary posted
This article was originally published in The Gray Sheet
Executive Summary
CBER's 1FY 2002 biological product deviation report annual summary notes that the center is reviewing comments on two 2001 draft guidances on criteria for reportable biological product deviations (BPD) and that CBER expects to issue the final guidances "in the near future." In vitro diagnostic manufacturers submitted 93 BPD reports in fiscal 2002, compared with 28 in 2001. The year-over-year jump in BPD reports for the IVD sector represents the largest increase among non-blood manufacturers...