Drug Regulators Are Trying to Quash Study, Senator Says
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Senator Charles E. Grassley charged on Friday that top federal drug regulators intend to suppress a study on the safety of Celebrex and Bextra.
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Congressional Democrats attacked US drug regulators on Wednesday for failing to track the Chiron Corp. plant where flu shots were found to be contaminated, leading to
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A U.S. Senate panel voted on Wednesday to set a path for generic drugmakers to seek approval of cheaper, copycat versions of expensive biotechnology medicines.
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Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency&#39;s approach to drug safety during a congressional hearing last week, said
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The US Food and Drug Administration asked David Graham, who last month told a Senate committee that the agency fails to protect the public from dangerous medicines, to leave his position
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Amid questions about whether the drug Vioxx was taken off the market soon enough, Senator Charles Grassley called for more safety precautions.
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Two US regulators defended the Food and Drug Administration's handling of the withdrawn painkiller Vioxx, disputing the contention of heart researcher Dr. Eric Topol that the agency could have forced Merck &amp; Co. to do more safety testing.
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A US lawmaker called on Wednesday for a probe of reports that Food and Drug Administration officials tried to discredit a veteran scientist who testified over Merck &amp; Co.
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Merck &amp; Co.&#39;s recall of the Vioxx painkiller shows why the US Food and Drug Administration needs its safety monitors to be independent of those who approve new medicines, FDA scientist David J. Graham told a Senate hearing.
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U.S. regulators said on Friday they would review a study showing a Merck and Schering-Plough cholesterol drug worked no better than a generic in preventing the build-up of arterial plaque.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist&#39;s warning that five drugs on the market have significant safety risks.
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The Food and Drug Administration has told a researcher that he cannot be part of an advisory panel that will meet early next year to review the safety of a class of drugs, COX-2 inhibitors, used to treat arthritis and pain.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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The U.S. Food and Drug Administration said on Friday that Senate testimony by a veteran FDA researcher regarding safety risks for five drugs does not reflect the views of the agency.
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A US government drug-safety scientist told lawmakers that the US Food and Drug Administration is &quot;virtually defenseless&quot; against a possible drug catastrophe like Merck&#39;s arthritis drug Vioxx.
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A member of the Senate said a diabetes expert leaked a confidential journal article to GlaxoSmithKline last year, tipping it to the publication of safety questions involving its drug Avandia.
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Doctors have been taking calls from anxious patients ever since a Senate hearing on Vioxx last week at which an FDA scientist expressed concerns about the safety of five other drugs on the market.