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Latest FDA News and Information
FDA allows marketing of first A1c test labeled for diagnosing diabetes
Today the U.S. Food and Drug Administration announced that it is allowing marketing of the COBAS INTEGRA 800 Tina-quant HbA1cDx assay (Tina-quant HbA1cDx assay) for the diagnosis of... read more
FDA expands alert to health care providers about lack of sterility assurance of all sterile drug products from NuVision Pharmacy
The U.S. Food and Drug Administration is alerting health care providers of concerns about a lack of sterility assurance of all sterile drug products made and distributed by NuVision... read more
FDA seeks preliminary injunction against New York fish manufacturer
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration (FDA), is seeking a preliminary injunction in the U.S. District Court for the... read more
FDA approves Simponi to treat ulcerative colitis
The U.S. Food and Drug Administration today approved a new use for Simponi (golimumab) injection to treat adults with moderate to severe ulcerative colitis.
Food and Drug Adminstration (FDA): CDRHNew
Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement
Meeting Announcement: June 26, 2013 General and Plastic Surgery Devices Panel of the Medical Devices Meeting Announcement
Consumer Information on: Selenia Dimensions 3D System - P080003S001
The Selenia Dimensions System with the C-View Software Module is a mammography device that provides digital 2D and 3D images for the screening and diagnosis of breast cancer.
Summary Information for: Selenia Dimensions 3D System
Labeling, Approval Order, and Summary of Safety and Effectiveness for Selenia Dimensions 3D System (P080003S001).
Federal Register: Cardiovascular Devices; Reclassification of External Counter-Pulsating Devices for Treatment of Chronic Stable Angina; Effective Date of Requirement for Premarket Approval for External Counter-Pulsating Devices for Other Specified Intended Uses
The FDA is issuing a proposed administrative order to reclassify external counter-pulsating (ECP) devices for treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without... read more
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Jobs at the Center for Biologics Evaluation and Research (CBER)
Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010
Procleix Ultrio Assay
Kcentra (Prothrombin Complex Concentrate, Human)
Approval Letter and Product Labeling, Posted: 4/30/2013
