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Category: Articles

Congressional Hearing on Proposed FDA Rule Change

04/2/2014
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Yesterday afternoon, Congress’s Subcommittee on Health held a hearing to examine the FDA’s proposal to change the rules of generic drug labeling. Under the current law, enacted in 1984, warning labels for particular drug formulations are created by the brand-name manufacturers, and generic manufacturers are legally prevented from altering them. […]

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The Penalty Game

03/31/2014
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Johnson and Johnson (J&J) and its subsidiary Janssen Pharmaceuticals have been dealing with multiple lawsuits stemming from its drug Risperdal. Shortly after dodging a $1.2 billion judgment in Arkansas, J&J has returned its focus to the multidistrict litigation (MDL) currently pending in Pennsylvania. The company is now trying to shield […]

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When Money Influences Medicine

03/27/2014
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The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson. Amid the hundreds of thousands of pages of documents provided in the 17,000 cases filed in federal court […]

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Living Off the Label

03/24/2014
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Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label promotion in its 2009 guidance, has set forth rules to restrict the […]

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Drug Supplement Endangers Kids

03/19/2014
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It is a supplement used to treat children with a genetic disorder but instead has hospitalized at least one child. The Food and Drug Administration (FDA) reports lots of L-citrulline, sold by Medisca, had none of the active drug. The Plattsburgh, N.Y.-based compounding company was forced to recall eight lots […]

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