Home > Newsletters > The QMN Weekly Bulletin > CBER Plan Aims to Speed AE Analysis, Reduce Phase III Failures
The QMN Weekly Bulletin
Aug. 17, 2012 | Vol. 4 No. 33
CBER Plan Aims to Speed AE Analysis, Reduce Phase III Failures
FDA’s Center for Biologics Evaluation and Research (CBER) hopes to speed studies of biologic adverse events within the next five years by using the FDA’s Mini-Sentinel postmarket surveillance pilot in partnership with other government agencies and private organizations.
CBER wants to pool larger data sets to better spot adverse events caused by biologics — events that may occur infrequently in small clinical trials.
The move, one of a number of regulatory science updates the center hopes to implement over the next five years, is outlined in its new strategic plan for regulatory science and research.
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