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Home » CBER Revises IGIV Trial Guidance, Says Historical Control May Be OK
CBER Revises IGIV Trial Guidance, Says Historical Control May Be OK
July 25, 2008
A statistical demonstration of a serious infection rate of less than 1 per person-year is adequate to provide substantial evidence of efficacy in clinical trials of investigational human immune globulin intravenous (IGIV) products, CBER says.