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TXT Teva Neuroscience Cited on Promotional Detailer [407 Words] [ Price : $7.95]
CDER cites Teva Neuroscience for a clozapine sales detailer that is allegedly misleading because it makes unsubstantiated superiority claims, omits material facts, and minimizes the drug’s risks.
04/22/2013
 
 
TXT FDA Safety Alert on Medical Bed Covers [240 Words] [ Price : $7.95]
An FDA safety alert warns healthcare providers about the potential for damaged medical bed mattress covers to allow blood and body fluids to penetrate the mattresses.
04/22/2013
 
 
TXT FDA Soothes ‘Alarmist’ View of Antibiotic Resistance Data [623 Words] [ Price : $7.95]
FDA rebuts an “inaccurate and alarmist” 4/15 report by the Environmental Working Group that said superbugs with foodborne antibiotic resistance have invaded meat found in supermarkets.
04/22/2013
 
 
TXT GE ‘Field Correction’ for Incubator Device [189 Words] [ Price : $7.95]
GE Healthcare begins a field corrective action involving its Giraffe Incubator with a Servo Control Oxygen System and Giraffe OmniBed due to settings being reset after an interruption in power.
04/22/2013
 
 
TXT FDA Approves Alcon NDA for Glaucoma Combo Drug [249 Words] [ Price : $7.95]
FDA approves an Alcon NDA for Simbrinza suspension, a combination drug indicated for reducing elevated intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension.
04/22/2013
 
 
TXT Draft Guidance Updates Device Component Testing for Toxicity [194 Words] [ Price : $7.95]
FDA issues a new draft guidance to assist the device industry in preparing submissions for devices that come into direct or indirect contact with the human body in order to determine their potential toxicity.
04/22/2013
 
 
TXT OMB OKs Info on Rx Drug Promotion [44 Words] [ Price : $7.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on a health care professional survey of prescription drug promotion.
04/19/2013
 
 
TXT OMB OKs Info on Device Small Business Qualification [57 Words] [ Price : $7.95]
Federal Register Notice: The Office of Management and Budget approves a collection of information on a guidance on medical device user fee small business qualification.
04/19/2013
 
 
TXT House Committee Hearing on Drug Supply Chain Security [514 Words] [ Price : $7.95]
The House Energy and Commerce health subcommittee plans a hearing 4/25 on “Securing Our Nation’s Prescription Drug Supply.”
04/19/2013
 
 
TXT FDA Clears a MedShape 510(k) for Tissue Anchor [89 Words] [ Price : $7.95]
FDA clears a MedShape 510(k) for its Eclipse Soft Tissue Anchor, a shape memory fixation device designed to attach a tendon, ligament or soft tissue to bone.
04/19/2013
 
 
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