federal_register: E8-16395

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E8-16395 [Docket No. FDA-2005-D-0208] (formerly Docket No. 2005D-0438) Notice The Food and Drug Administration (FDA) is announcing the availability of a 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 June 2008. The guidance document provides recommendations for the design of clinical trials to assess the safety, efficacy, and pharmacokinetics of immune globulin intravenous (human) (IGIV) products as replacement therapy in primary humoral immunodeficiency. The guidance announced in this notice finalizes the draft guidance of the same title dated November 2005. 2008-07-17 2008 7 https://www.federalregister.gov/documents/2008/07/17/E8-16395/docket-no-fda-2005-d-0208-formerly-docket-no-2005d-0438 https://www.govinfo.gov/content/pkg/FR-2008-07-17/pdf/E8-16395.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for...  

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