Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency, dated November 2005. The document gives recommendations (for sponsors designing clinical trials) for testing the safety, efficacy, and pharmacokinetics of immune globulin intravenous (human) (IGIV) products as replacement therapy in primary humoral immunodeficiency. To download the guidance, click here. To view this notice, click here.