Six Months After It Announced Start Of This Investigation, FDA Gives An Update On Status Of Maxipime Safety Review read more »
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The newest culprit in the direct-to-consumer (DTC) television ad cat and mouse game between pharmaceutical manufacturers and US regulators is Cordis, a medical device subsidiary of Johnson & Johnson. read more »
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As Dr. Robert Hauser said: "Just because a device is FDA-approved does not necessarily mean it is safe." read more »
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In 2004, the European Commission adopted a new directive that paved the way for legal approval of biosimilars in the European Union (EU). To date, five (5) biosimilars have garnered marketing approva read more »
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On May 14, 2008 a House of Representative's Committee will convene a hearing to explore the legal doctrine of federal preemption in the context of product liabilitliability lawsuits involving FDA-ap read more »
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North Carolina Board Of Pharmacy Has Posted A Copy Of The Bertek Digitek Drug Recall Notice On Its Web Site read more »
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Although we slave all day and into the night over a warm laptop at the Pharmalot corporate headquarters, every so often we venture out to speak to this or that group about pharma matters or blogging. read more »
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Drugmakers will soon be able to use data from foreign clinical trials in new drug applications even if trials only compare new products to placebos instead of best available treatments. The change de read more »
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On May 8, 2008 Public Citizen's Health Research Group (HRG) sent its "Petition to the FDA to Ban Ortho-Evra" to Commissioner Andrew von Eschenbach. In this 11-page letter, Sidney Wolfe, M.D., the Dir... read more »
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