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BPD rule yields 35% jump in biologic adverse reports; labeling a leading cause.

Publication: Warning Letter Bulletin
Publication Date: 16-DEC-02 		Format: Online - approximately 659 words
Delivery: Immediate Online Access

Article Excerpt
Dear Reader,

Biological product deviation (BPD) reporting regulations and guidance have yielded about a 35% increase in adverse reports filed with the Center for Biologics in fiscal 2002 compared with fiscal 2001.

According to CBER data, first released at the American Assn. of Blood Banks (AABB) annual meeting in October and posted on CBER's web site Nov. 27, BPDs jumped from 24,218 in fiscal 2001 to 33,846 in fiscal 2002 (ended Oct. 1).

Fiscal 2002 was the first full fiscal year for BPDs, which replaced "error and accident reporting." The BPD rule became effective May 7,...

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