Pharmaceutical approval process under fire
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A day after troubling reports about the popular pain relief drug Celebrex, more questions are being asked about the approval process for such drugs.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
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Proposed legislation could spell changes across the pharmaceutical world.
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WASHINGTON &#151; When federal regulators delayed approving a promising new prostate cancer therapy, patients and the drug&#146;s advocates reacted with more than disappointment.
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This has not been an especially good year for regulatory government agencies, with their accompanying acronyms. Let&#39;s begin with the Food and Drug Administration (FDA), which can&#39;t quite make up its mind which drug will kill us first - or how quickly.
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WASHINGTON &#151; Safety concerns about a GlaxoSmithKline diabetes drug prompted some Democratic lawmakers on Wednesday to rebuke the Food and Drug Administration and call for increased regulation of the pharmaceutical industry.
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If its latest drug isn't approved, the pharmaceutical could face trouble.
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THE future of AstraZenecaâs blood-thinning medicine, Exanta, was thrown into fresh doubt last night after Franceâs leading drugs regulator confirmed that it was reviewing the medicineâs approval status.
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The issue of drug advertising directly aimed at consumers is becoming political.
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The FDA decides to debate the company's lead drug.
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Nov. 19, 2004 -- New allegations from an FDA scientist that the agency is failing at its job of ensuring the safety of the drugs it approves has many Americans thinking twice before taking their daily dose.
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The US regulator to beef up monitoring of drug safety after criticism over a painkiller linked to heart disease.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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WASHINGTON There&#39;s already controversy erupting around a summit on arthritis drug safety, months before the meeting is set to start.
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Almost one-fifth of agency scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations.
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The public outcry over the withdrawal of the painkiller Vioxx is leading to closer government scrutiny of new drugs to identify and disclose late-developing safety problems.
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NEW YORK - As doctors struggle to come to grips with what the withdrawal of Vioxx means for drug safety, the letters pages of the normally sedate New England Journal of Medicine have turned into a battleground.