FDA Says Stands by Safety of Approved Drugs
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The US Food and Drug Administration said on Friday that Senate testimony by a veteran FDA researcher regarding safety risks for five drugs does not reflect the views of the agency.
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NEW YORK - An internal survey conducted by the Food and Drug Administration (FDA) indicates that 66% of FDA scientists lacked confidence that the agency adequately monitors the safety of prescription drugs that are already on the market.
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A top Food and Drug Administration official said on Thursday she disagrees with an agency scientist's warning that five drugs on the market have significant safety risks.
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Americans should feel reasonably safe taking government-approved prescription drugs &#151; with a few caveats &#151; even after a popular arthritis medication was pulled from the market, medical experts say. But the problems with Vioxx raise questions about the Food and Drug Administration's safety review process and the length of time it took Merck to pull the drug, observers say.
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An internal survey of Food and Drug Administration scientists conducted by the Health and Human Services Office of the Inspector General revealed safety concerns about the FDAâs approval process and monitoring of marketed drugs, according to a press
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British drug firms have defended the safety of two products which were deemed unsafe by an American expert. Dr David Graham listed five medicines which he said posed serious health risks during a US Senate hearing.
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Washington, Dec 16 : One-fifth of the US Food and Drug Administration (FDA) scientists surveyed as part of an official review have said they had been pressured to recommend approval of a new drug despite their reservations about its safety, effectiveness
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After two highly publicized incidents questioning the safety of some of the biggest selling prescription medicines, the Food and Drug Administration said yesterday it is moving to strengthen its safety monitoring efforts.
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Leading medical journal editors and lawmakers have rightfully focused a spotlight on how well the Food and Drug Administration monitors the safety of drugs after they are approved.
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WASHINGTON -- The Food and Drug Administration plans to revamp how it handles safety issues with the stents, pacemakers, implantable defibrillators and other medical devices it regulates.
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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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Responding to continuing criticism about its warning policies, the Food and Drug Administration said Friday it will strengthen its system for reviewing the safety of drugs already on the market.
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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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Most Americans say they're confident about the safety of prescription drugs sold in the United States, according to an Associated Press poll taken at a time when several popular medications have been linked to increased risk of heart attack and stroke.
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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 Bush administration and some of its critics squared off over whether the Food and Drug Administration is doing an adequate job overseeing drug safety, and whether the agency needs major reforms. White House Chief of Staff Andrew H. Card Jr. said it is doing a "spectacular" job.
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The US Food and Drug Administration denied charges it tried to suppress a safety official&#39;s findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.