Department of Health and Human Services December 1, 2005 – Federal Register Recent Federal Regulation Documents
Results 1 - 3 of 3
Change of Address; Technical Amendment
The Food and Drug Administration (FDA) is amending its regulations to reflect a change in the address for the American Society for Testing Materials (ASTM). This action is editorial in nature and is intended to improve the accuracy of the agency's regulations.
Draft Guidance for Industry on Safety, Efficacy, and Pharmacokinetic Studies to Support Marketing of Immune Globulin Intravenous (Human) as Replacement Therapy for Primary Humoral Immunodeficiency; Availability
The Food and Drug Administration (FDA) is announcing the availability of 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 The draft guidance document provides recommendations for testing the safety, efficacy, and pharmacokinetics of immune globulin intravenous (human) (IGIV) products as replacement therapy in primary humoral immunodeficiency. The draft guidance document is intended to assist sponsors with the design of clinical trials to assess IGIV as replacement therapy in primary humoral immunodeficiency.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device Recall Authority
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
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