Drug Approval Process Concerns Many FDA Scientists
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An internal survey found that about two-thirds of FDA scientists lack confidence in the agency&#39;s monitoring of the safety of prescription drugs now on the market.
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Doctors have been taking calls from anxious patients ever since a Senate hearing on Vioxx last week at which an FDA scientist expressed concerns about the safety of five other drugs on the market.
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A new drug that can treat patients with multiple sclerosis has been approved by the Food and Drug Administration but the high cost of the medication has some people concerned.
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The regulatory approval was also a boost for the embattled drugs sector. It was feared that, following a series of safety crises, the US Food and Drug Administration would get tougher on new drugs.
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A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according to documents jointly released today by the Union of Concerned
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Congress is looking into whether the Food and Drug Administration ignored safety concerns about the drug raised by its own reviewers and outside scientists.
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The U.S. Food and Drug Administration on Friday asked an outside group to review the way the agency monitors safety risks of medicines after they hit the market, such as Merck & Co. Inc.'s withdrawn painkiller Vioxx.
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If its latest drug isn't approved, the pharmaceutical could face trouble.
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The problems with Vioxx, taken off the market last week, raise questions about the Food and Drug Administration's safety review process. Observers say longer clinical trials should be required.
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The Food and Drug Administration is considering allowing pharmaceutical makers to provide doctors with medical journal studies of unapproved uses for drugs, a move critics say would undermine long-standing restrictions on marketing medicines for "off-label" purposes.
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Neurologists urge caution upon reports of a successful therapy.
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Dr. David Graham, the Food and Drug Administration scientist who publicly criticized the agency&#39;s approach to drug safety during a congressional hearing last week, said
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New data are due out on a promising cholesterol drug. But there are doubters.
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Critics charge conflict of interest in a system where pharmaceutical giants fund the regulatory process. By Alexandra Marks | Staff writer of The Christian Science Monitor.
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The FDA, which has been under criticism for its lengthy approval process, this week approved two new drugs for multiple sclerosis and cancer treatment.
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By , New York Times. Dozens of former and current Food and Drug Administration officials, outside scientists and advocates for patients say that the agency&#39;s efforts to monitor the ill-effects of drugs that
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The approval of a new drug is a long-term opportunity.