Zdrowie i gospodarka · 01/12/2005

FDA Releases Draft Guidance for Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency

The FDA has released a draft guidance document outlining recommendations for testing the safety, efficacy, and pharmacokinetics of IGIV products as replacement therapy for primary humoral immunodeficiency, aiming to assist sponsors in designing clinical trials for this purpose.