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Category: Blog

The Ortho Evra Label Changes:

07/14/2008
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Are They Timely Ortho-FDA Collaborative Warnings, Or Are They FDA Sanctioned Excuses for the Manufacturer The FDA has been in the news quite often, recently. Lately, consumers have seen news about caustic and blinding eye care solutions (Bausch & Lomb’ ReNu MoistureLoc and AMO’s Complete MoisturePlus), E. coli in spinach, […]

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Big Tobacco and their Bean Counters

07/3/2008
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So, what is Big Tobacco doing these days in the Florida “Engle” litigation? Are they aggressively trying to bring cases to trial so they can be vindicated? Are they conducting important investigation and discovery in an effort to further justice? Ah, not so much. I speak with clients each day […]

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Pain Pumps and Disappearance of Shoulder Cartilage

07/2/2008
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Several companies, including Stryker, BREG, Inc., I-Flow and DJO, Inc. have manufactured and distributed high volume pain pumps. During surgery and for up to three days afterward, doctors use a variety of pain pumps to deliver anesthesia to shoulder joints. These pain pumps have catheters that surgeons can implant into […]

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What Has Gone Wrong With the Davol Kugel Hernia Patch?

06/23/2008
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Let’s take a closer look at one of the Davol patents, which provides the “blueprint” for the Kugel Mesh Hernia Prosthesis (Canadian Patent CA 2 357 020). A brief review of Davol’s patent shows that the oval shaped Kugel Patch is made from a mesh that will not dissolve, and […]

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“FDA 101” The FDA Wants to Know

06/11/2008
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In the wake of the new Current Good Manufacturing Process (CGMP) the FDA has now posted “FDA 101 How to Use the Consumer Complaint System and Med Watch” to deal with the growing issue of unsafe and contaminated products that include dietary supplements.

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It’s Herbal So It Must Be Safe—Right?

06/6/2008
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Not necessarily. The herbal product industry is still a largely unregulated industry and historically we know that many of America’s Corporate Citizens have a hard time policing themselves. When those spreadsheets hit the boardroom tables in Big Corporations, it can be difficult for them to consider safety and not focus […]

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Herbal Supplements – What you Need to Know

05/21/2008
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A lot has happened since 1994 when the FDA decided to let “their hair down” and deregulate the Herbal Supplement Industry at the pleas of “naturalists” who demanded that the government and pharmaceutical industry were in a conspiracy to keep these less costly “natural products” out of the hands of […]

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