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FDA Toughening Rules For Infusion Pumps

Following a number of complaints, the Food and Drug Administration is issuing preliminary guidelines requiring that manufacturers of infusion pumps provide adequate test data before it will approve commercial sale of the devices. The dangers of defective medical devices are extreme. Their purpose is to improve patient health, not to cause injury or death. When […]

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New Setback for Pfizer On Sutent Drug Study

The pharmaceutical behemoth Pfizer has found yet another problem with a drug that it is testing against a wide range of cancers, following a review by the independent Data Monitoring Committee. The company recently announced that it was discontinuing a late-stage Phase III study of its drug Sutent for use in treating liver cancer. “The […]

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Two Antibiotics Recalled by Drug Maker

Two antibiotics have been voluntarily recalled by their manufacturer, Ranbaxy Laboratories Inc., in Jacksonville, Florida due to a small number of complaints received concerning the powdered form of the drugs changing colors when mixed with water. The two drugs, Amoxicillin and Clavulanate Potassium for Oral Suspension (Lot No. 1910779 and 1910782) are currently available in […]

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Avandia Given Positive Reviews Due to $$$$$?

And so the Avandia saga continues. A recent analysis of articles and reviews about the type 2 diabetes drug manufactured by drug giant, GlaxoSmithKline, indicates that experts who were paid by Glaxo consistently gave more positive reviews concerning the drug’s efficacy and safety than those not paid by Glaxo. Hundreds of studies have been performed […]

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The FDA and Drug Approval

The United States Food and Drug Administration (FDA) is charged with ensuring the efficacy and safety of many different products, many of which are drugs and medical devices. Once a drug is approved by the FDA, consumers like to believe the drug is safe. Unfortunately, however, that is not always the case. You will often […]

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J&J Planned Profit from Risky, Unapproved Uses of Risperdal

According to documents unsealed in relation to a lawsuit over off-label marketing of a dangerous drug, Johnson and Johnson planned to improve its market share for drugs used to control elderly dementia, a use not approved by the FDA. The plan was made just months after the company had already been criticized for marketing materials […]

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