Update 4: FDA Wants More Safety Data on Merck Drug
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The Food and Drug Administration told Merck &amp; Co. that it requires further safety and efficacy data before it will approve its successor drug to now defunct pain reliever Vioxx, the pharmaceutical maker announced Friday.
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Merck & Co. MRK.N on Friday said  U.S. regulators have decided not to approve the company's  experimental arthritis drug, the successor to its recalled  Vioxx pill, until more safety and effectiveness data are  obtained.
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The Food and Drug Administration needs more staff, funding and authority over the drug industry to better track the safety of medicines after they reach the market, an Institute of Medicine report said Friday.
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Medicines watchdogs are reviewing safety data for an entire class of drugs taken by millions of patients with arthritis and severe pain after the worldwide withdrawal of Merck&#39;s Vioxx last week.
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The US Food and Drug Administration today announced a five-step program to bolster drug safety evaluations. The news comes after controversy over the recall of the arthritis drug Vioxx and risks to children on antidepressants.
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Faced with pressure from lawmakers and editors of medical journals, four trade groups representing the world's biggest drug makers said yesterday that their members planned to release more data about clinical drug trials.
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The US Food and Drug Administration (news - web sites) on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck &amp; Co.
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Merck & Co. said on Wednesday it plans  to release data from a study of its recalled arthritis drug  Vioxx at a meeting of specialists later this month.
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ROCKVILLE, Md.  - The U.S. Food and Drug  Administration on Friday asked an outside group to review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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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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A veteran U.S. Food and Drug  Administration scientist will unveil new data on Thursday  before an expert panel charged with determining whether pain  relievers similar to Merck & Co. Inc.'s now-withdrawn Vioxx  should remain on the market.
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The Food and Drug Administration told Merck &amp; Co. that it would approve the company&#39;s successor drug to the now defunct pain reliever Vioxx if it provides further safety and efficacy data, the big pharmaceutical company announced Friday.
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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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&quot;We were wrong about Vioxx, but you can trust us on all those other meds,&quot; the FDA seems to be saying. If you enjoy this article, you may also be interested in an article entitled &#39;The FDA remains in state of denial about drug safety questions.
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Pfizer Inc. said Friday that it will provide health-care professionals with additional information about its Bextra arthritis drug and that it will conduct further studies to confirm the drug&#39;s long-term cardiovascular safety record.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way it monitors safety risks associated with medicines already on the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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Swiss drug maker Novartis Pharma AG said Monday that the Food and Drug Administration has again requested more information on the company&#39;s Certican treatment, when used in combination with Neoral, to prevent heart and kidney transplant rejection episodes