F.D.A. to Create Advisory Board on Drug Safety
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The Food and Drug Administration is responding to the widespread criticism of the government's handling of drug safety problems.
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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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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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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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The Food and Drug Administration would gain new 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 Wednesday by the House.
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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 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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Senator Judd Gregg (USA) does not like the idea of a new independent bureau responsible for drug safety. He says all it would achieve would be more layers of FDA bureaucracy.
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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's ability to monitor prescription drug side effects, the panel's chairman said in a letter released on Thursday.
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WASHINGTON - Federal health advisers considering more stringent warning labels for antidpressants linked to suicidal thoughts among children told the Food and Drug Administration on Tuesday that they may consider more than just a label change.    One member of the panel asked the drug agency whether they could require that those prescribing the drugs undergo training to better recognize warning signs...
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The U.S. Food and Drug Administration said on Tuesday it was creating an independent drug safety board after the agency's monitoring of drugs already in the marketplace was criticized amid the withdrawal of arthritis drug Vioxx.
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The American Medical Association&#39;s policy-making board could make a decision today about supporting the safe importation of prescription drugs.
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Dec. 23, 2004 - The Food and Drug Administration today issued a Public Health Advisory summarizing the agency&#39;s recent cautions and recommendations concerning the use of non-steroidal anti-inflammatory drug
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Dr. Lester Crawford's nomination comes amid widespread calls that the F.D.A. strengthen oversight of drug safety.
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A House subcommittee approved legislation yesterday that would give US regulators new power to oversee drug safety by ordering changes on pharmaceutical labels and forcing drug makers to conduct studies of products after they're on the market.
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The U.S. Food and Drug  Administration said on Tuesday it was creating an independent  drug safety board after the agency's monitoring of drugs  already in the marketplace was criticized amid the withdrawal  of arthritis drug Vioxx.
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The US Food and Drug Administration, facing a barrage of criticism from both within and outside the agency, announced plans Friday to improve the safety of drugs after they have been approved.