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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

A Message from the Director, Division of Mammography Quality Standards (DMQS): EQUIP

First, I want to thank everyone for the very positive feedback we have received about the series of articles on MQSA topics which we launched in 2015. We are glad that... read more

MQSA National Statistics

In this section of MQSA Insights, we present the most commonly requested national statistics regarding the MQSA program. These statistics are updated on the first of each month.

Transcripts posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Transcripts posted for November 9-10, 2016 Microbiology Devices Panel of the Medical Devices Advisory Committee

Class I Medical Device Recall: Medtronic Recalls Neurovascular Products due to Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating

Medtronic is recalling of certain lots of its Pipeline embolization device, Alligator retrieval device, X-Celerator hydrophilic guidewire, and UltraFlow and Marathon flow-directed micro catheters.

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

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

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

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