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Power Morcellator – A Deadly Twist

04/13/2015
Defective Medical Devices
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The power morcellator, a surgical device used to mince large masses of tissue inside the body so the material can be extracted through small incisions, has been the center of a debate in the medical community since the Food and Drug Administration (“FDA”) discouraged its use in April, 2014. The FDA discouraged the use […]

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Benicar – The Hidden Dangers

04/6/2015
Common Questions
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On January 9, 2015, the Department of Justice announced that Daiichi Sankyo, a Japanese corporation who has its United States headquarters in New Jersey, was fined $39 million as a result of violating the False Claims Act by paying kickbacks to physicians to induce them to prescribe drugs manufactured by […]

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Levaquin Blamed for Neuropathy, and Other Serious Side Effects

03/30/2015
Articles
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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
Articles
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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
Articles
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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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