How drug-approval woes crept up on FDA
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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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If its latest drug isn't approved, the pharmaceutical could face trouble.
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The Food and Drug Administration over the past decade has shifted its budget away from monitoring the safety of drugs on the market, focusing more and more on approving new medicines.
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The Food and Drug Administration of the US found itself in the midst of a rather unpleasant controversy. Recently the chief of Cleveland Clinic Foundationâs department of cardiovascular medicine blamed this
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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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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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As drug makers are increasingly scrutinized for their relationships to researchers, the Cleveland Clinic Foundation's chief academic officer is finding himself under the spotlight.
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The federal Food and Drug Administration, the agency charged with protecting an American public that is more and more dependent on pharmaceuticals, has been falling down on its job.
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Taking a look at how drug approval rates have fared under different FDA commissioners.
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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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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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The case of China's former FDA leader highlights the issues facing the country's pharmaceutical industry.
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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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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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Between the controversy over drug reimportation and activism from a certain state&#39;s attorney general, it has been a nasty year for the pharmaceutical industry.
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In a sharp change of direction, many medical authorities are questioning the safety of American drugs. In a challenge unthinkable even two months ago, Dr.
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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.