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.
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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
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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
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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.
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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
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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...
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