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FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes

The U.S. Food and Drug Administration today approved a new indication for Jardiance (empagliflozin) to reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and... read more

Food regulators seize adulterated milk products for food safety violations

The U.S. Food and Drug Administration announced today that the U.S. Marshals Service seized more than 4 million pounds of product produced by Valley Milk Products LLC (Valley Milk)... read more

FDA research to help speed development of Zika virus vaccines and therapeutics

A new mouse model developed by scientists at the U.S. Food and Drug Administration may help in exploring the potential activity of Zika virus vaccines and therapeutics. Published today... read more

FDA approves Intrarosa for postmenopausal women experiencing pain during sex

The U.S. Food and Drug Administration approved Intrarosa (prasterone) to treat women experiencing moderate to severe pain during sexual intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA),... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Medical Devices; Neurological Devices; Classification of the Computerized Cognitive Assessment Aid for Concussion

The FDA is classifying the Computerized Cognitive Assessment Aid for Concussion into class II (special controls). The special controls that will apply to the device are identified in this order... read more

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Providing Information About Pediatric Uses of Medical Devices

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are... read more

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are... read more

Federal Register: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Device: Current Good Manufacturing Practice Quality System Regulations

The 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... 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

Fluarix

For active immunization against influenza for individuals 3 years of age or older and to include the data from pediatric clinical studies with revision of the prescribing information.

FluLaval Quadrivalent

FluLaval

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