FDA's biologics center unveils guidance for IGIV product trials

07/27/2008 | FDAnews

Sponsors of investigational human immune globulin intravenous products need to show a rate of serious infections of less than one per person-year in pivotal clinical trials to sufficiently demonstrate efficacy, according to guidance from the FDA's Center for Biologics Evaluation and Research. The guidelines also review the various study-design strategies that may work for such trials.

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