U.S. report faults FDA oversight of drug trials
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A report to be released on Friday  finds the U.S. Food and Drug Administration does very little to  ensure the safety of patients who help test drugs in clinical  trials, The New York Times reports.
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A Food and Drug Administration reviewer who has criticized the agency for being lax in monitoring drug safety said on Thursday five medicines on the market need close scrutiny for possible side effects.
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WASHINGTON - About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
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All studies to date provide inconsistent data about the potential contribution of GlaxoSmithKline Plc's diabetes drug Avandia to heart attack risk, the head of the Food and Drug Administration said in testimony prepared for a congressional hearing on Wednesday.
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WASHINGTON - The US pharmaceutical industry that exports billions of dollars worth of medicine around the world faced new scrutiny Friday after a survey revealed nearly one-fifth of its government overseers had experienced pressure to approve drugs they
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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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About two-thirds of Food and Drug Administration scientists are less than fully confident in the agency&#39;s monitoring of the safety of prescription drugs now being sold, according to an FDA internal survey.
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The U.S. Food and Drug Administration failed the public in its oversight of Merck & Co Inc.'s painkiller Vioxx, which has been withdrawn, and is "incapable of protecting America" from another dangerous drug, an agency researcher told Congress on Thursday.
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Federal drug regulators are "virtually incapable of protecting America" from unsafe drugs, a federal drug safety reviewer told a Congressional panel.
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Congress has been investigating the FDA&#39;s decisions in both the Vioxx and antidepressant cases. The probes have focused on agency reviewers who warned about potential problems but claimed their research was ignored or suppressed by other officials.
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Nearly 20 percent of U.S. Food and  Drug Administration scientists surveyed in late 2002 said they  were pressured to approve or recommend approval of a medicine  despite their reservations about the drug's risks or  effectiveness, according to documents made public on Thursday.
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New reports accuse another drug company of being too slow to pull a dangerous medication from the market and question the ability of the federal Food and Drug Administration to protect the public from such risks.
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Importing cheaper prescription drugs should not come at the expense of safety, said a US government report issued on Tuesday that highlighted the problems of ensuring the medicines are equivalent to those in the United States.
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Responding to public criticism of its handling of the controversial arthritis drug Vioxx, the US Food and Drug Administration on Wednesday defended its oversight of the monitoring process and said it acted in the best interests of the public&#39;s safety.
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The system to monitor the hidden, harmful effects of widely prescribed drugs is broken. Congress should consider creating an agency independent of the Food and Drug Administration to keep watch over an industry
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A drug safety reviewer said the FDA is "incapable of protecting" the public and urged the government to review five new drugs for safety issues.
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The U.S. Food and Drug  Administration failed the public in its oversight of Merck & Co  Inc.'s MRK.N withdrawn painkiller Vioxx and is "incapable of  protecting America" from another dangerous drug, an agency  researcher told Congress on Thursday.