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Researchers Working on Heart-powered Pacemaker

[ Price : $8.95]

University of Buffalo engineering researchers say they are building a prototype of a pacemaker that would operate without batterie...

Docket Established for Input on Technologies in Clinical Trials

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Federal Register Notice: FDA establishes a public docket to solicit input on the use of technologies and innovation in conducting ...

Integrity Applications Meets With CDRH on Glucose Tracker

[ Price : $8.95]

Integrity Applications says it recently met with CDRH officials to discuss its clinical trial protocol for GlucoTrack Model DF-F, ...

Sanofi Recalls Auvi-Q Due to Dosage Concerns

[ Price : $8.95]

Sanofi recalls all Auvi-Q (epinephrine injection, USP) due to the potential for inaccurate dosage delivery.

Warner Chilcott Guilty Plea in Drug Kickback Scheme

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Warner Chilcott agrees to plead guilty to a felony charge of health care fraud and pay $125 million to resolve its criminal and ci...

Info on Clinical Investigators Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on financial disc...

OMB OKs Info on Biosimilar Sponsor Meetings

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Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on meetings betwee...

FDA Approves Novartis Combo Bronchodilator COPD

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FDA approves a Novartis NDA for its dual combination bronchodilator Utibron Neohaler (indacaterol/glycopyrrolate) inhalation powde...

NEJM Editorial Backs Califf as Next FDA Commissioner

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A New England Journal of Medicine (NEJM) editorial throws support behind FDA Office of Medical Products and Tobacco deputy commiss...

FDA Approves Expanded Use in Melanoma for BMS Yervoy

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FDA approves an expanded use for Bristol-Myers Squibbs Yervoy (ipilimumab) adjuvant therapy for patients with Stage III melanoma ...