F.D.A. Widens Safety Reviews on New Drugs
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The F.D.A. plan is the latest effort to fix the agency after a series of missteps.
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Britain is to overhaul and open up its  drug safety monitoring system, already viewed as one of the  better schemes worldwide, in the wake of recent scandals over  the side effects of some medicines.  Patients will in future be able to view anonymous data on  suspected adverse drug reactions on the Medicines and  Healthcare Products Regulatory Agency's (MHRA) Web site, Health  Minister Lord Warner said Monday.
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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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The story of COX-2 drugs is an example of how difficult it is for the F.D.A. to monitor the safety of drugs after they have been approved for the market.
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Dr. Steven Galson, acting director of the Food and Drug Administration&#39;s Center for Drug Evaluation, announced Friday that the FDA will review five popular drugs whose safety is being questioned.
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The results from the new clinical trial could increase the chances that the Food and Drug Administration will approve the drug for that use.
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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 US 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 &amp; Co.
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The pharmaceutical industry made a commitment Thursday to publish more data about clinical drug trials, amid growing questions about the safety of many leading companies' medicines.
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The Food and Drug Administration yesterday called for an evaluation of all prevention studies involving two controversial painkillers - Celebrex and Bextra - to ensure adequate protection for participants who use the pills.
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Britain is to overhaul and open up its drug safety monitoring system, already viewed as one of the better schemes worldwide, in the wake of recent scandals over the side effects of some medicines. Patients will in future be able to view anonymous data on suspected adverse drug reactions on the Medicines and Healthcare Products Regulatory Agency's (MHRA) Web site, Health Minister Lord Warner said Monday.
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The U.S. Food and Drug Administration issued a new report on Tuesday describing potential risks of several medicines after criticism that it was lax in policing drugs once they were on the market.
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Among the potential modifications are more frequent testing and additions to the list of banned substances to strengthen its testing program for performance-enhancing drugs .
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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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Government regulators now look to approve as quickly as possible medicines whose benefits exceed their risks.
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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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Scrutiny of other pain relievers urged over fear they, too, may lead to heart problems. By Marilynn Marchione. Momentum was growing for a fresh look at the safety of Celebrex and other pain relievers as key