Drug approval process flawed
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THE US pharmaceutical industry that exports medicines around the world is facing further scrutiny after a survey revealed nearly one-fifth of its government overseers had experienced pressure to approve drugs about which they had reservations.
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The drug maker's difficulties are evident, but its productivity may make it worth a second look.
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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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Thereâs an inherent conflict of interest when the government conducts comparative-effectiveness studies and then uses those studies to determine which pills are worth buying.
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The federal system for approving and regulating drugs is in serious disrepair, and a host of dramatic changes are needed to fix the problem, a blue-ribbon panel of government advisers concluded yesterday in a long-awaited report.
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Nearly a quarter of follow-up studies required by the Food and Drug Administration for medical devices in recent years were never completed, according to a senior
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The US Food and Drug Administration, under fire for its alleged failure to monitor the safety of drugs after they have been approved, is now facing criticism over its lack of leadership during the Bush administration.
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The FDA is being accused of approving drugs too quickly, in 1992 Congress passed a new law so that the FDA could speed up drug approvals.
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The Food and Drug Administration does very little to ensure the safety of the millions of people who participate in clinical trials, a federal investigator has found.
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Physicians frequently fail to  provide patients with all the information they should have when  they're prescribed new medication, investigators in California  report.
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IT&#39;S HARD TO SEE how the country&#39;s drug safety agency will emerge unscathed from a string of failures -- nor should it. Devastating scandals, touching millions of lives, demand a tough appraisal of a fumbling agency that has lost its way.
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Critics charge conflict of interest in a system where pharmaceutical giants fund the regulatory process.
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Â· Inquiry slams mis-prescribing of drugsÂ· Doctors 'ignoring official guidelines'
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A key U.S. lawmaker said on Thursday he had not yet seen a workable approach to creating an approval pathway for generic versions of expensive biotechnology medicines.
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Weighing the risks of Avandia, a diabetes drug, against its benefits is a difficult task.
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Faced with weak development pipelines that are putting a drag on stock prices, drug manufacturers are retooling the decades-old system of clinical trials to make it faster and cheaper.
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Not every drug invented in the laboratory is worth developing into a marketable product.