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Other links at Articles > Business of Medicine |
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FDA Reprimands GlaxoSmithKline Over Missing Data on Rosiglitazone
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In a letter to GlaxoSmithKline, the FDA said that an inspection in late 2007 focusing on compliance with postmarketing adverse drug experience reporting requirements found that the company failed to report data from clinical usage and failed to disclose or submit data from clinical trials. Heartwire
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Schering, Merck Shares Fall on Congressional Probe
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Shares of Schering-Plough Corp and Merck & Co were down on Wednesday after U.S. lawmakers said they would look into allegations that the drugmakers were withholding data from a study of their shared cholesterol medicine Vytorin. Reuters Health Information
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U.S. Inspects Few Foreign Drugmakers, Congress Told
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U.S. regulators inspect few foreign makers of pharmaceutical ingredients and have no accurate count of how many companies supply the American market, a watchdog arm of Congress said on Thursday. Reuters Health Information
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