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TXT Injectafer Video Promotes Unapproved Use: OPDP [660 Words] [ Price : $8.95]
CDERís Office of Prescription Drug Promotion says a video segments for Luitpoldís Injectafer promotes the drug for unapproved new uses, omits material information, and makes misleading claims.
02/05/2015
 
 
TXT Commissioner Hamburg Leaving FDA Next Month [3429 Words] [ Price : $8.95]
After nearly six years at the helm, FDA commissioner Margaret Hamburg steps down at the end of next month.
02/05/2015
 
 
TXT Better Research Needed to Stimulate Innovation: Paper [497 Words] [ Price : $8.95]
The Brookings Institutionís Gregory Daniel says a new database should be developed to shed greater light on the factors affecting biomedical innovation.
02/05/2015
 
 
TXT DTC Violations Vary With Medium: Analysis [305 Words] [ Price : $8.95]
An Eye on FDA blog says that the types of direct-to-consumer ad violations found by the CDER Office of Prescription Drug Promotion in 2014 vary according to the communications medium used.
02/05/2015
 
 
TXT Six-year Sentence for Lilly Drug Robbery [267 Words] [ Price : $8.95]
A Connecticut federal judge sentences Yosmany Nunez to six years in prison for his part in the 2010 theft of prescription drugs from a Lilly warehouse.
02/05/2015
 
 
TXT FDA OKs Medtronicís Pipeline Flex Embolization Device [147 Words] [ Price : $8.95]
FDA approves a Medtronic PMA for the Pipeline Flex embolization device, its latest-generation flow diversion device for use in large and giant brain aneurysm treatment.
02/05/2015
 
 
TXT FDA Grants Ignyta Orphan Status for Lung Cancer Drug [121 Words] [ Price : $8.95]
FDA grants Ignyta an orphan drug designation for entrectinib and its use in treating TrkA-positive, TrkB-positive, TrkC-positive, ROS1-positive and ALK-positive non-small cell lung cancer.
02/05/2015
 
 
TXT FDA OKs AorfixPlus for More Abdominal Aneurysms [87 Words] [ Price : $8.95]
FDA approves Lombard Medicalís AorfixPlus endovascular stent graft for treating patients with abdominal aortic aneurysms in an expanded range of proximal neck diameter sizes up to 36mm.
02/05/2015
 
 
TXT Sans Breakthrough, Merck Still Filing NDA for Hep C Drug [164 Words] [ Price : $8.95]
Merck plans to file an NDA soon for its hepatitis C combination therapy after FDA withdrew its breakthrough therapy designation.
02/04/2015
 
 
TXT Astellas Agrees to Clinical Trial Data Transparency [167 Words] [ Price : $8.95]
Astellas Pharma says it will make its clinical trial data available through an independent Web site that enables researchers to request and access data after approval of a research proposal by an independent review panel.
02/04/2015
 
 
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