FDA seeks more safety data on Vioxx successor
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Merck &amp; Co. said the US Food and Drug Administration has requested additional safety and efficacy information on its Vioxx successor, Arcoxia, before it considers granting US approval for the drug.
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The Food and Drug Administration insists that until pharmaceutical giant Merck presented new information this week, there was not enough evidence to pull the arthritis drug Vioxx off the market.
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The U.S. Food and Drug Administration said on Tuesday it was creating an independent drug safety board after the agency's monitoring of drugs already in the marketplace was criticized amid the withdrawal of arthritis drug Vioxx.
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U.S. Food and Drug Administration  officials pressured an agency safety official to keep quiet or  water down his findings that the now-withdrawn arthritis drug  Vioxx was dangerous to the heart, a leading Senate Republican  charged on Thursday.
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The FDA (USA) says it did not try to suppress the findings of a safety official regarding the Vioxx painkiller. Vioxx was taken off the market last week because the drug increases a patient&#39;s risk of having a heart attack.
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The US Food and Drug Administration will ask the Institute of Medicine to study the agency&#39;s safety monitoring of medicines already on the market, Acting FDA Commissioner Lester Crawford said on Friday.
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Merck & Co. on Friday said U.S.  regulators won't approve its experimental arthritis drug  Arcoxia until the company provides more data showing it is safe  and effective.
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Drug giant Merck says the Food and Drug Administration wants more information, but is prepared to approve the company&#39;s successor drug to recalled pain reliever Vioxx.
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As expected, FDA officials on Friday announced plans to improve the procedures used by the agency to monitor the safety of medications after they reach the market, the Newark Star-Ledger reports.
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NEW YORK -- The pharmaceutical industry yesterday said it plans to publish more data about clinical drug trials, despite skepticism about whether the initiative will increase transparency and improve drug safety.
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Responding to continuing criticism that it mishandled internal warnings that the painkiller Vioxx had deadly side effects and that antidepressants were
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Responding to continuing criticism about its warning policies, the Food and Drug Administration said Friday it will strengthen its system for reviewing the safety of drugs already on the market.
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The U.S. Food and Drug   Administration needs more staff, funding and power over the   drug industry to better police the safety of medicines after   they reach the market, an Institute of Medicine panel said on   Friday.
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Heart problems that pushed the painkillers Bextra and Vioxx off the market could have come to light earlier had federal regulators given outside researchers speedier access to raw safety data, according to a commentary written by Boston researchers.
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The world's leading drug companies have promised to publish more data about clinical trials into new medicines to reassure the public about their safety.
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Just days before a medical journal was to publish a Food and Drug Administration-sponsored study that raised concerns about the safety of the arthritis drug Vioxx, an FDA official
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The safety of Merck&#39;s (MRK:NYSE - news - research) Vioxx has been questioned again with the posting of an internal Food and Drug Administration study on the agency&#39;s website.