FDA Panel Gives Preliminary OK for Study
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A new Food and Drug Administration ethics panel said Friday the advancement of science outweighed the risks of giving a stimulant to healthy children as young as 9.
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The U.S. Food and Drug Administration 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to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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Drug maker Merck &amp; Co. Inc. on Tuesday said its board appointed a committee to review the company&#39;s actions prior to the voluntary withdrawal of its painkiller Vioxx.
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Almost one-fifth of the Food and Drug Administration scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite
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The U.S. Food and Drug Administration will announce on Tuesday it will create an independent drug safety oversight board as a new measure to strengthen the safety of drugs already in the marketplace, an administration official said.
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GAITHERSBURG, Maryland  - A U.S. advisory panel on Friday was divided over whether current data warrant changes to drug-coated heart stent labels for their use in patients with more medical complications unapproved for the device.
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WASHINGTON - The Food and Drug Administration would gain authority to ensure the safety of prescription drugs, including the power to mandate label changes that warn of newly emerging risks, under a bill passed yesterday by the House.
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FDA could make a decision within days on whether to adopt an advisory panel&#39;s recommendations to include a black box warning about the increased risk of suicidal tendencies that antidepressants pose for children, and any labeling changes could be
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A new panel of outside experts will advise the U.S. Food and Drug Administration on how to tell the public about the risks and benefits of medicines and medical devices, the agency said on Monday.
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Drug maker Merck & Co. Inc. on  Tuesday said its board appointed a committee to review the  company's actions prior to the voluntary withdrawal of its  painkiller Vioxx.
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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A panel of US experts on Wednesday unanimously agreed that a new Sanofi-Aventis meningitis vaccine has been shown to be safe and effective, but said follow-up data was needed.
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An FDA advisory panel votes favorably on Adolor's lead drug.
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A U.S. House of Representatives committee voted on Thursday to give the Food and Drug Administration more power to monitor the side effects of medicines after they reach the market.
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A House of Representatives  subcommittee is expected to take up legislation next week meant  to bolster the Food and Drug Administration&#39;s ability to  monitor prescription drug side effects, the panel&#39;s chairman  said in a letter released on Thursday.
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WASHINGTON -- Another Food and Drug Administration advisory committee agreed that it&#39;s OK to give healthy children doses of a stimulant as part of an experiment.
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WASHINGTON - A federal scientific advisory panel meets tomorrow to consider whether to recommend that a skin patch to enhance women&#39;s desire for sex should be licensed as a new drug.