FDA to assess antibiotic linked to woes
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Federal health officials said Thursday they would ask outside experts whether the benefits of an antibiotic linked to rare reports of severe liver problems, including several deaths, outweigh its benefits.
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The Food and Drug Administration reportedly is reviewing internal Eli Lilly documents that suggest the anti-depressant Prozac may be linked to violent behavior.
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The Food and Drug Administration announced Friday its intentions to conduct a major evaluation of its approach in dealing with safety concerns involving drugs, primarily those that are already marketed.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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October 1, 2004 5:11 PM GMT (Datamonitor) - The Food and Drug Administration (FDA) is set to examine the potential link between antidepressants and increased suicidal tendencies in adults.
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The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.
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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review the  way it monitors safety risks associated with medicines already  on the market, such as Merck & Co. Inc.'s withdrawn painkiller  Vioxx.
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The U.S. Food and Drug  Administration plans to update antidepressant labels to reflect  studies that suggest a link between the drugs and suicide in  youths, but remains cautious about the strength of such ties,   according to documents released on Friday.
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U.S. lawmakers criticized the Food and Drug Administration's monitoring of the risks of the antibiotic Ketek (Sanofi-Aventis) and some other prescription drugs on Tuesday.
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The Food and Drug Administration will examine clinical trial data for thousands of depressed adults to see if they, like children, suffered increased suicidal thoughts and behaviors while taking antidepressants.    Dr...
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U.S. health authorities on Wednesday said they will conduct an investigation to get to the bottom of an unexplained illness marked by skin lesions that do not heal and a batch of other symptoms.
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NEW YORK, December 24  - The Food &amp; Drug Administration (FDA) announced yesterday that it planned to examine the various studies that link the usage of several painkillers with heightened cardiovascular risks, while recommending that
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The U.S. Food and Drug Administration plans to update antidepressant labels to reflect studies that suggest a link between the drugs and suicide in youth, according to documents released on Friday.
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The Food and Drug Administration expects to seek tougher measures regulating the use of antidepressants when it convenes an advisory panel meeting next month, according to agency documents released yesterday.
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The troubles surrounding a major class of painkillers may ultimately help cure what has long ailed the US Food and Drug Administration.
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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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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.