CBER Five-Year Plan Aims to Speed Adverse Event Analysis, Cut Down on Phase III Failures

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. The center wants to pool larger data sets to better spot adverse events caused by biologics. These events can occur infrequently in small clinical trials.
Drug Industry Daily