US FDA to Review Post-Market Safety Checks
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ROCKVILLE, Md.  - 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to review the  way the agency monitors safety risks of medicines after they  hit the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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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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U.S. health officials said on Friday they would review whether to take regulatory action over Merck & Co Inc and Schering-Plough's cholesterol medicine Vytorin following the drug's failure to work better than a generic drug in a study of plaque build-up in neck arteries.
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The U.S. Food and Drug Administration  expects to inspect Boston Scientific Corp.'s Galway, Ireland  factory in the "near future" as part of its probe into the  company's coronary stent recall, the Wall Street Journal said  on Friday.
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The Food and Drug Administration said last night it would convene a public panel to examine the risk of blood clots in patients with drug-coated stents, among the world's most frequently implanted medical devices.
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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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British and US regulators continued their inspection of a contaminated vaccine factory in Liverpool, England, as the health agencies for both countries sought on Saturday to clarify how the problems unfolded that likely have cut the United States&#39; flu
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The Food and Drug Administration came under withering criticism by a House panel yesterday for its handling of recent food-safety violations, and the Bush administration later disclosed plans to establish a working group to review the safety of food and other imports.
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The U.S. Food and Drug   Administration needs more staff and funding to fix its   monitoring of drug safety after medicines are on the market,   the Institute of Medicine (IOM) said on Friday.
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U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's and Schering-Plough Corp's popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.
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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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The US Food and Drug Administration on Thursday ordered the review of preventative studies involving Pfizer Inc.&#39;s painkillers Celebrex and Bextra, in light of recent evidence they may increase the risk of heart attack and stroke.
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The Food and Drug Administration will establish a new independent Drug Safety Oversight Board to monitor FDA-approved medicines once they're on the market and update physicians and patients with emerging information on risks and benefits.
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A Food and Drug Administration reviewer who has criticized the agency for being lax in monitoring drug safety said on Thursday five medicines on the market need close scrutiny for possible side effects.
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Responding to public criticism of its handling of the controversial arthritis drug Vioxx, the US Food and Drug Administration on Wednesday defended its oversight of the monitoring process and said it acted in the best interests of the public&#39;s safety.
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Congress is looking into whether the Food and Drug Administration ignored safety concerns about the drug raised by its own reviewers and outside scientists.
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The US Food and Drug Administration expects to inspect Boston Scientific Corp.&#39;s Galway, Ireland factory in the &quot;near future&quot; as part of its probe into the company&#39;s coronary stent recall, the Wall Street Journal said on Friday.