FDA Scientists Issued Early Warnings on Drug Approvals
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A previously unpublished internal survey of Food and Drug Administration scientists points to potentially dangerous gaps in the approval and marketing of prescription drugs, according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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The Food and Drug Administration needs more staff, funding and authority over the drug industry to better track the safety of medicines after they reach the market, an Institute of Medicine report said Friday.
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Responding to a spate of deaths in clinical trials, the Food and Drug Administration yesterday issued its most severe warning possible for drugs widely used to treat anemia in kidney disease patients and cancer patients undergoing chemotherapy.
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The U.S. Food and Drug Administration is facing new questions about its ability to police the safety of medicines after they reach the market following concerns about a widely used diabetes drug.
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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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Almost one-fifth of agency scientists surveyed two years ago as part of an official review said they had been pressured to recommend approval of a new drug despite reservations.
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Weeks before President Bush announced a plan to protect African babies from AIDS, top U.S. health officials were warned that research on the key drug was flawed and may have underreported severe reactions including deaths, government documents show.
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Food and Drug Administration experts are recommending new label warnings about possible dangerous psychiatric side effects of influenza drugs Tamiflu and Relenza, according to FDA documents.
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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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U.S. drug safety regulators are  coming under fire for their response to years of suspicions,  confirmed last week, that arthritis drug Vioxx increased the  risks of heart attacks and strokes.
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An FDA official named and shamed several drugs offered by major drugs companies, causing their shares to fall sharply in early trading.
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Nearly 20 percent of US Food and Drug Administration scientists surveyed in late 2002 said they were pressured to approve or recommend approval of a medicine despite
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U.S. drug safety regulators are coming under fire for their response to years of suspicions, confirmed last week, that arthritis drug Vioxx increased the risks of heart attacks and strokes.
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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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The US Food and Drug Administration, facing a barrage of criticism from both within and outside the agency, announced plans Friday to improve the safety of drugs after they have been approved.
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Federal advisers who met last week to consider whether to restrict doses of popular antianemia drugs were themselves under scrutiny during the hearing. The Food and Drug Administration is considering a top-to-bottom reshaping of how it picks and uses the outside scientists who serve on the agency's advisory panels.
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WASHINGTON - A new Food and Drug Administration analysis backs earlier suggestions of a link between at least some antidepressants used by children and suicidal tendencies, prompting the agency to prepare new warnings.    Exactly what those warnings will say, and which drugs will be affected, hasn't been settled, according to FDA documents released Friday...