An advisory committee to the U.S. Food and Drug Administration is scheduled to meet in February to discuss the safety of the drugs.
At the district court level, the company asserted that the truth fully entered the market anyway via FDA announcements as well as analyst reports disclosing all material information regarding the safety of the drugs in question.
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According to Raghu Chundawat, a Delhi-based wildlife scientist who is not connected to the project, any long-term suspension of the radio-collar programme would be a "disaster" for the Sundarbans, and doubts about the safety of the drugs are "absolute nonsense".
Consumers in rich countries have grown used to the idea that the government takes responsibility for everything from the stability of the banks that take their deposits to the safety of the drugs on sale in the local pharmacy, or their rights to refunds when goods are faulty.
The withdrawal ignited a firestorm of controversy about the safety of other drugs, like Celebrex and Bextra, from Pfizer (nyse: PFE - news - people ).
The FDA has received additional reports of esophageal cancer in people taking oral bisphosphonates since 2009, says Wysowski, an epidemiologist at the branch of the agency responsible for tracking the safety of drugs after they have been approved.
On Wednesday, a panel of pediatricians will consider the safety of drugs like Ritalin and Adderall that are commonly used to treat attention deficit disorder.
Originally designed for the pharmaceutical industry to test the safety and effects of drugs, the authors have pioneered RCTs to test the claims that small, uncollateralized loans to the poor are a persuasive antidote to poverty.
The Institute of Medicine has just released a visionary report on how we should study the safety of approved drugs.
FDA, and the medical system as a whole, to monitor the safety of drugs after they have been approved, and about the power of the regulator to mandate changes to drug labelling and advertising.
The women were convicted of vehicular homicide and assault, but the verdict was based on driving with disregard for the safety of others rather than on driving under the influence of drugs.
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Older, over-the-counter pain medicines may not be safe for the heart, McKinnell said, because there is no way of tracking the cardiovascular or stomach safety of older arthritis drugs.
Researchers hope that if the ongoing preliminary studies prove the safety and effectiveness of these drugs for certain treatments, the government will step in to fund larger trials.
The FDA may be learning not to sit on data too long, for fear of losing control of the public debate about the safety and efficacy of particular drugs.
And, of course, the problem of accounting for unknown adverse effects has never been more acute for the drug industry, with intense and costly political controversies over the safety profile of drugs like Vioxx and Avandia leading to panic among patients, outrage among politicians, and the inevitable endgame of costly withdrawals and lawsuits.
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Prominent doctors are calling for congressional investigations, and European regulators are scrutinizing the safety of similar drugs such as Pfizer's Bextra and Celebrex.
This post-New Deal legislation empowered the FDA to require pre-market evidence of the safety of new drugs, such as by testing on animals.
This fraction is likely to decrease further as FDA demands ever-larger, ever-more expensive clinical trials to accumulate data on the safety of drugs in development.
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The panel is also concerned about the safety of older drugs like ibuprofen and diclofenac, and perhaps Abbott Laboratories ' (nyse: ABT - news - people ) Mobic, which has seen its sales skyrocket as a result of Celebrex's problems.
And it would give the FDA the power to fine companies to force them to do safety studies or change the labels of drugs.
Indeed, in America, the Tourette Syndrome Association felt it necessary to issue a statement warning of the paucity of long-term safety data, especially in children, and the potential interactions of nicotine with drugs given to treat the syndrome.
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That follows a Feb. 1 article in The New England Journal of Medicine that questioned the safety data available for these drugs.
As you know, on September 16, 2010, FDA held a meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (Advisory Committee) to discuss the safety and efficacy of lorcaserin, a drug developed by Arena Pharmaceuticals, Inc. (Arena) to treat obesity.
Currently much data that are relevant to the safety and effectiveness of approved drugs are beyond public view.
But so far, the PDUFA fees are used only to review the safety and efficacy of drugs before they are approved.
In preparing for the July 2010 meeting of the Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, the FDA sought to provide the committee members with all available data relevant to the cardiovascular safety of rosiglitazone.
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The former administrative law judge said he had bought a "very, very large position in Arena" after he spent many hours studying the safety of lorcaserin versus other diet drugs.
In an unprecedented move that could signal dramatic changes in the drug industry, GlaxoSmithKline is promising to make detailed data from its clinical trials available to independent researchers so that scientists can draw their own conclusions about the safety and effectiveness of its new drugs.
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Every year, the number of drugs on the market that need to be monitored for safety increases--and that number has soared exponentially since the FDA was founded.
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