2014

Blog Posts in 2014

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  • FDA Delays Issuing New Generic Drug Label Rule

    Posted By Golomb & Honik || 31-Dec-2014

    A new proposed rule that will allow generic drug makers to update their own safety warnings on labels has been delayed until the fall of 2015. The new rule has been labeled as “controversial” because it would give the makers of generic drugs the ability independently update safety warnings. This is currently something that only brand-name drug makers are allowed to do prior to ...
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  • Takata Believes Evidence Doesn't Support National Recall

    Posted By Golomb & Honik, P.C. || 30-Dec-2014

    A December 3 rd news report stated Takata Corporation defied a U.S. safety agency's demand for a recall of potentially deadly driver's side airbags. This refusal to recall the airbags leaves many motorists worried about the safety of their vehicle, and also potentially sets the stage for governmental legal actions and sanctions. Takata claims their own internal testing supports issuing ...
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  • Morcellators Get Black Box Warning

    Posted By Golomb & Honik, P.C. || 30-Dec-2014

    Laparoscopic power morcellators, used during hysterectomies and for the removal of uterine fibroids, have been given a Black Box warning by the U.S. Food and Drug Administration (FDA). After nearly one year of debate, the FDA decided in November to issue its strongest possible warning against the morcellators rather than ban them. Power morcellators have been in use since the 1990s, with their ...
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  • 30,000 Pounds of Chicken Kiev Recalled over Salmonella Concerns

    Posted By Golomb & Honik || 28-Dec-2014

    If you have uneaten chicken kiev in your freezer, don’t eat it until you verify that it was not included in a recent recall. On October 24, 2014, the USDA Food Safety & Inspection Service issued a recall of almost 30,000 pounds of chicken kiev due to a possible link to salmonella. To date, at least six illnesses have been linked to this particular chicken. The recalled chicken kiev can ...
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  • Research Sheds Light on Benicar Abdominal Pain

    Posted By Golomb & Honik, P.C. || 27-Dec-2014

    Recent studies indicate that abdominal pain associated with Benicar, may be related solely to that drug rather than being a side effect of all angiotensin receptor blockers (ARBs)- drugs designed to relax blood vessels and lower blood pressure. Many patients have reported suffering significant Benicar side effects including sprue-like enteropathy, causing serious abdominal pain and chronic ...
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