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TXT Compounding Pharmacy Recalls Sterile Drugs Over Sterility Concerns [195 Words] [ Price : $7.95]
Balanced Solutions Compounding Pharmacy recalls all lots of its sterile non-expired drug products due to sterility assurance and product quality control concerns.
04/22/2013
 
 
TXT Senate HELP Committee Draft Legislation on Track-and-Trace [475 Words] [ Price : $7.95]
With a House hearing on the same topic set for 4/25, a Senate committee releases draft legislation on a track-and-trace system to protect the drug distribution chain.
04/22/2013
 
 
TXT FDA OKs Warner Chilcott Oral Contraceptive [44 Words] [ Price : $7.95]
FDA approves Warner Chilcott’s Minastrin 24 FE for preventing pregnancy.
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TXT Draft Guidance Updates Device Component Testing for Toxicity [194 Words] [ Price : $7.95]
FDA issues a new draft guidance to assist the device industry in preparing submissions for devices that come into direct or indirect contact with the human body in order to determine their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 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 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 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
 
 
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