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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

What's New: Vaccines, Blood & Biologics RSS Feed

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

Phlebotomy System 1.0.0

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