Federal Agency Disputes Pill's Benefits
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Federal officials Wednesday backed away from the findings of two major studies on birth control pills, saying the research was flawed and that a new analysis shows there is no evidence that oral contraceptives cut the risk of heart disease.
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Group that protects whistle-blowers says the FDA tried to discredit an outspoken safety officer who was challenging the agency's drug safety policies.
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An expert with the Food Drug Administration has accused the agency in Congress of having pressed him to withhold results of a study showing potential dangers of the anti-inflammatory drug Vioxx.
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The Food and Drug Administration  said yesterday that it is making changes in the way it operates to prevent the kind of drug safety controversies that have dogged the agency in recent years.
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U.S. lawmakers criticized the Food  and Drug Administration's monitoring of the risks of a  Sanofi-Aventis antibiotic and some other prescription drugs on  Tuesday.
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BITTER PILL: Federal officials say research was flawed in two major studies showing oral contraceptives cut the risk of heart disease and carried no increased risk of breast cancer - results contrary to many previous findings.
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A federal advisory panel voted unanimously yesterday that the first drug to enhance the sex drive of women should not be approved because of a lack of information about its long-term safety.
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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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With new warnings on an abortion pill, the Food and Drug Administration has given conservative medical advice. Whatever factors may have gone into the change, the FDA must focus on science, not conservative politics.
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Plan B, an emergency contraceptive, is under review again by the Food and Drug Administration after it previously denied over-the-counter sale of the drug. Women's groups charge the decision was political, not scientific.
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A series of drug-safety scandals has led many on Capitol Hill to question whether the F.D.A. has failed to strike the right balance between speed and safety.
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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.
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Sanofi- Aventis SA's weight loss pill Acomplia shouldn't be approved in the United States because the company hasn't showed that the benefits outweigh the risk of suicidal thoughts among those taking the drug, an advisory panel said.
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WASHINGTON Dec 22, 2004 - The Food and Drug Administration is seeking to block an ad touting the safety of the cholesterol drug Crestor, calling the claims misleading.
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U.S. regulators on Friday delayed a decision on whether to approve over-the-counter sales of a Barr Pharmaceuticals "morning-after pill" to prevent pregnancy, prompting a lawsuit from a women's rights group.
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The U.S. Food and Drug Administration denied charges it tried to suppress a safety official's findings that painkiller Vioxx, which was pulled from the market last week, raised heart attack risks.
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Questions about billing, coverage and prices of drugs covered under the new prescription benefit were routinely wrong, the government finds.