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.
When it comes to labeling unexpected events during a clinical trial, most investigators agree: The answer isn’t always obvious. The definitions — and the required responses — vary from one agency to the next.
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