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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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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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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THE future of AstraZenecaâs blood-thinning medicine, Exanta, was thrown into fresh doubt last night after Franceâs leading drugs regulator confirmed that it was reviewing the medicineâs approval status.
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The approval of a new drug is a long-term opportunity.
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Every year, doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs.
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While treatments have multiplied, the operations and processes for delivering those medicines haven't kept pace, slowing health improvement in developing and developed countries. Alexis Madrigal reports from the AAAS annual meeting in Boston.
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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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Doctors are missing key information they need to make decisions for cancer patients because some drug companies are not publishing clinical trials.
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Because of PfizerÂs failed trial, drugs similar to torcetrapib from other companies could face greater scrutiny Â and delays Â in getting to market.
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Concern over the recently publicized risks of drugs such as Vioxx and Celebrex has left doctors and patients with difficult choices.
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The Food and Drug Administration lacks clear regulatory authority and is chronically underfunded, shortcomings hindering its ability to evaluate the safety of drugs used by millions of Americans, according to outside scientists the agency asked to critique its performance.
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The market might overlook the drug maker's promising programs.
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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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Be aware of the Medicare drug plan's gaps.
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The government&#39;s research on using an AIDS drug to protect African babies was so flawed that health officials had to use blood tests after the fact to confirm patients got the medicine.
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The FDA is about to make it harder for drug-eluting stents to win its approval.