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Latest FDA News and Information

FDA approves new treatment for diabetic retinopathy in patients with diabetic macular edema

The U.S. Food and Drug Administration today expanded the approved use for Eylea (aflibercept) injection to treat diabetic retinopathy in patients with diabetic macular edema.

FDA approves treatment for inhalation anthrax

The U.S. Food and Drug Administration today approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.

FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures

The U.S. Food and Drug Administration today approved the Impella 2.5 System, a miniature blood pump system intended to help certain patients maintain stable heart function and circulation during certain... read more

FDA concludes Arctic Apples and Innate Potatoes are safe for consumption

Today, the U.S. Food and Drug Administration completed its evaluation for two varieties of apples genetically engineered by Okanagan Specialty Fruits, Inc., and for six varieties of potatoes genetically... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Medical Devices; Neurological Devices; Classification of the Brain Injury Adjunctive Interpretive Electroencephalograph Assessment Aid

The FDA is classifying the brain injury adjunctive interpretive electroencephalograph assessment aid into class II (special controls). The special controls that will apply to the device are identified in this... read more

Reminder - Public Workshop ? FCC/FDA Joint Workshop on Wireless Medical Device Test Beds, March 31, 2015

On Tuesday, March 31, 2015, the Federal Communications Commission and the Food and Drug Administration will host a public workshop on the role of wireless medical test beds and their influence on... read more

Olympus Validates New Reprocessing Instructions for Model TJF-Q180V Duodenoscopes

As noted in FDA?s February 2015 Safety Communication, the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and... read more

Presentation Slides added to Public Workshop - Complexities in Personalized Medicine: Harmonizing Companion Diagnostics Across a Class of Targeted Therapies, March 24, 2015

The purpose of the workshop is to facilitate an in-depth discussion of harmonization of companion diagnostic devices across a class of targeted therapies. The workshop aims to foster collaborations in... 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

Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products; Guidance for Industry

Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine

Package Insert and Patient Information - Rotarix

CBER Rotarix Product Approval Information

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