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Category: Articles

Summary Judgment Upheld in Boston Scientific Vaginal Mesh Case

11/30/2015
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On February 9, 2009, a North Carolina resident was implanted with the Obtryx Transobturator Mid-Urethral sling. This patient filed suit against the maker of her vaginal mesh, Boston Scientific (“Boston”), asserting claims of breach of express and implied warranties, negligence, punitive damages, and strict liability (design defect, failure to warn, and […]

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NIH Drug-Making Laboratory Shut Down due to Fungus Fears

06/9/2015
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It’s a scary day when even the federal government can’t keep a laboratory sterile for drug-making. Following the New England Compounding Center (NECC) fungal outbreak in 2012, the Food and Drug Administration (FDA) has shut down the government’s own compounding pharmacy run by the National Institutes of Health (NIH) over […]

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Essure and Bayer Under Fire

05/6/2015
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The FDA recently announced that it is investigating allegations of improprieties in conjunction with clinical trials that were conducted by Bayer and Conceptus with regard to the Essure device, which is utilized in sterilization procedures. Bayer Corporation, a German pharmaceutical giant, purchased Conceptus, the original designer of the Essure device, […]

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Levaquin Blamed for Neuropathy, and Other Serious Side Effects

03/30/2015
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A reported 100,000 Americans, including a 54-year-old Illinois man and 36-year-old North Carolina woman, have reported severe side effects from Levaquin, an antibiotic that packs enough pill power to kill anthrax. Levaquin, a drug classified in the fluoroquinolone family, is now undergoing another Food and Drug Administration evaluation because of the controversy. Twelve […]

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FDA Drug Approvals off the Charts for 2014

03/17/2015
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New Medications Meet Unmet Patient Needs The Food and Drug Administration’s approval of 41 novel new drugs in 2014 made it a banner year for the pharmaceutical industry. The class of 2014 included biologicals, drugs that treat cancer and infectious diseases (bacterial, fungal, parasitic and viral) and therapeutic drugs. The […]

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Lengthy Clinical Trial Process Gets Overhaul by FDA

03/10/2015
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Safeguarding, streamlining, strengthening the clinical trial process is one of three of the Food and Drug Administration’s primary goals for 2015. So states an 11-page document titled 2014 – 2015 Strategic Priorities. The other two goals focus on 1) striking a better balance between data collection requirements and the time […]

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